AzTrials
AzTrials

Primary Immunodeficiency Diseases (PID)Phase 2/3NCT01218438

Phase 2/3 Study of IGSC, 20% in PIDD

A Phase 2/3 study testing Immune Globulin Intravenous (Human), 10% Solution and Immune Globulin Subcutaneous (Human), 20% Solution in people with Primary Immunodeficiency Diseases (PID), run by Baxalta now part of Shire at 18 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to develop a 20% subcutaneous (SC) immunoglobulin preparation for the treatment of patients with primary immunodeficiency diseases (PIDD). Read more about this study

Who is it for?
Ages 2 years and older
Conditions the study is for
Primary Immunodeficiency Diseases (PID)
What is being tested?
Immune Globulin Intravenous (Human), 10% Solution and Immune Globulin Subcutaneous (Human), 20% Solution
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
86 participants
Where
18 sitesin 2 countries
Study dates
28 Jan 2013to 13 Mar 2015
Phase
Phase 2/3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 2 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Main Inclusion Criteria:

  • Documented diagnosis of a form of primary humoral immunodeficiency involving defective antibody formation and requiring gammaglobulin replacement as defined according to the IUIS Scientific Committee, 2011 and by diagnostic criteria according to Conley et al. (1999). The diagnosis must be confirmed by the Medical Director prior to first treatment with the investigational product (IP) in the study.
  • Participant is 2 years or older at the time of screening, and has a minimum body weight of 13 kg.
  • Written informed consent has been obtained from either the participant or the participant's legally authorized representative prior to any study-related procedures and study product administration
  • Participant has been receiving a stable monthly equivalent dose of IgG at an average minimum dose equivalent to 300 mg/kg bodyweight (BW)/4 weeks and a maximum dose equivalent to 1.0 gram/kg BW/4 weeks, for a minimum of 12 weeks prior to first treatment with the IP in the study.
  • Serum trough level of IgG > 500 mg/dL at screening
  • Participant is willing and able to comply with the requirements of the protocol

Main Exclusion Criteria:

  • Participant has known history of or is positive at screening for one or more of the following: hepatitis B surface antigen (HBsAg), polymerase chain reaction (PCR) for Hepatitis C virus(HCV), PCR for human immunodeficiency virus (HIV) Type 1/2
  • Abnormal laboratory values at screening meeting any one of the following criteria (abnormal tests may be repeated once to determine if they are persistent):
  • Persistent alanine aminotransferase (ALT) and aspartate amino transferase(AST) > 2.5 times the upper limit of normal for the testing laboratory
  • Persistent severe neutropenia (defined as an absolute neutrophil count [ANC] ≤500/mm^3)
  • Creatinine clearance (CLcr) value that is < 60% of normal for age and gender either measured, or calculated according to the Cockcroft-Gault formula
  • Malignancy (other than adequately treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix), unless the disease-free period prior to screening exceeds 5 years
  • Participant is receiving anti-coagulation therapy (low dose aspirin at ≤325 mg/day is permitted) or has a history of thrombotic episodes (including deep vein thrombosis, myocardial infarction, cerebrovascular accident, pulmonary embolism) or sickle cell disease with crisis within 12 months prior to screening or a history of thrombophilia
  • Abnormal protein loss (protein losing enteropathy, nephrotic syndrome)
  • Anemia that would preclude phlebotomy for laboratory studies according to standard practice at the site
  • Acute serious bacterial infection within 3 months prior to screening
  • Ongoing history of hypersensitivity or persistent reactions (urticaria, breathing difficulty, severe hypotension, or anaphylaxis) following intravenous immunoglobulin, subcutaneous immunoglobulin, and/or Immune Serum Globulin (ISG) infusions
  • Severe immunoglobulin A (IgA) deficiency (less than 0.07g/L) with known anti-IgA antibodies and a history of hypersensitivity
  • Participant is on continuous systemic antibacterial antibiotics at doses sufficient to treat or prevent bacterial infections, and, in the opinion of the investigator, cannot stop these for the duration of the study without putting the patient at risk of increased infections
  • Participant has active infection and is receiving antibiotic therapy for the treatment of infection at the time of screening
  • Bleeding disorder or thrombocytopenia with a platelet count less than 20,000/μL, or who, in the opinion of the investigator, would be at significant risk of increased bleeding or bruising as a result of subcutaneous therapy
  • Total protein > 9 g/dL or myeloma or macroglobulinemia (IgM) or paraproteinemia
  • Severe dermatitis that would preclude adequate sites for safe product administration
  • Women of childbearing potential meeting any one of the following criteria:
  • Participant presents with a positive pregnancy test
  • Participant is breast feeding
  • Participant intends to begin nursing during the course of the study
  • Participant does not agree to employ adequate birth-control measures (e.g. intrauterine device, diaphragm or condom [for male partner] with spermicidal jelly or foam, or birth control pills/patches) throughout the course of the study
  • Participation in another clinical study and exposure to an investigational product or device within 30 days prior to study enrollment (exception: treatment in a previous Baxter immunoglobulin study)
  • Participant is scheduled to participate in another (non-Baxter) non-observational (interventional) clinical study involving an investigational product or device during the course of the study

Trial locations and contacts

18 sites in 2 countries.

18 sites in 2 countries

United States16 sites

  • Emory University

    Atlanta, Georgia, 30322

  • IMMUNOe International Research Centers

    Centennial, Colorado, 80112

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • Dallas Allergy Immunology Research

    Dallas, Texas, 75230

  • University of California, Irvine

    Irvine, California, 92697

  • Allergy Asthma and Immunology Clinic PA

    Irving, Texas, 75063

  • Rocky Mountain Asthma/Allergy/Immunology

    Layton, Utah, 84041

  • Family Allergy and Asthma Research Institute

    Louisville, Kentucky, 40215

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Children's Hospital New Orleans- LSUHSC School of Medicine

    New Orleans, Louisiana, 70118

  • Allergy Associates of the Palm Beaches

    North Palm Beach, Florida, 33408

  • Oklahoma Institute of Allergy and Asthma Clinical Research

    Oklahoma City, Oklahoma, 73131

  • Midwest Immunology Clinical and Infusion Center

    Plymouth, Minnesota, 55446

  • SSM Cardinal Glennon Children's Medical Center

    St Louis, Missouri, 63104

  • Montefiore Medical Center Division of Allergy/Immunology

    The Bronx, New York, 10461

  • Vital Prospects Clinical Research Institute, PC

    Tulsa, Oklahoma, 74136

Other trials in United States

Canada2 sites

  • Centre Hospitalier Universitaire (CHU) Sainte-Justine

    Montreal, Quebec, H3H 1C5

  • Montreal Children's Hospital- McGill University health Center

    Montreal, Quebec, HEH 1P3

Other trials in Canada

About this study

Official title: A Clinical Study of Immune Globulin Subcutaneous (Human), 20% Solution (IGSC, 20%) for the Evaluation of Efficacy, Safety, Tolerability and Pharmacokinetics in Subjects With Primary Immunodeficiency Diseases (PIDD)

The purpose of this study is to develop a 20% subcutaneous (SC) immunoglobulin preparation for the treatment of patients with primary immunodeficiency diseases (PIDD).

Being tested
Immune Globulin Intravenous (Human), 10% Solution, Immune Globulin Subcutaneous (Human), 20% Solution
Medical subject headings
Primary Immunodeficiency Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Immune Globulin Intravenous (Human), 10% SolutionBiological

    Also called IGIV, 10%

    Intravenous infusion with IGIV, 10%

  • Immune Globulin Subcutaneous (Human), 20% SolutionDrug

    Also called IGSC, 20%

    Subcutaneous infusion with IGSC, 20%

Study groups in NCT01218438
Study groupRoleWhat they receive
Study Epochs 1-4ExperimentalEpoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study. Epoch 2 (12-16 weeks): PK assessment (in first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated subcutaneously every 7 days at a dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1. Epoch 3 (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined. Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion.
Receives: Biological: Immune Globulin Intravenous (Human), 10% Solution; Drug: Immune Globulin Subcutaneous (Human), 20% Solution

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of Acute Serious Bacterial Infections Per Year (ASBI)

    Annual rate of validated acute serious bacterial infections was calculated using a Poisson model to account for the different lengths of observation per participant. The observation period for each participant starts with the day of the first subcutaneous (SC) infusion in Study Epoch 2 and ends with the day of the End of Study visit.

    Measured: 1 year

Secondary outcomes (80)

  1. Annual Rate of All Infections Per Participant

    Measured: 1 year

  2. Annual Rate of Sinus Infections Per Participant

    Measured: 1 year

  3. Annual Rate of Fever Episodes Per Participant

    Measured: 1 year

  4. Annual Rate of Days Off School/Work or Days Unable to Perform Normal Daily Activities Due to Illness or Infection Per Participant

    Measured: 1 year

  5. Annual Rate of Days on Antibiotics Per Participant

    Measured: 1 year

  6. Annual Rate of Hospitalizations for Illness or Infection Per Participant

    Measured: 1 year

  7. Annual Rate of Days of Hospitalizations for Illness or Infection Per Participant

    Measured: 1 year

  8. Annual Rate of Acute (Urgent or Unscheduled) Physician Visits, or Visits to the Emergency Room for Illness or Infection Per Participant

    Measured: 1 year

  9. Bioavailability of IGSC, 20% as Measured by the Ratio of the Geometric Means of Immunoglobulin G (IgG) AUCSC (Epoch 4) to IgG AUCIV,0-τ (Standardized to 1 Week) (Epoch 1) Adjusted for Dose and Dosing Frequency (Participants ≥12 Years Old)

    IGSC, 20% = Immune Globulin Subcutaneous (Human), 20% Solution; AUCSC = area under the concentration-time curve following subcutaneous administration; AUCIV,0-τ = area under the concentration-time curve following intravenous administration over a dosing interval

    Measured: Epoch 1: 3 week IV administration interval: Week 10, 11, 12, 13. Epoch 1: 4 week IV interval: Week 9, 10, 11, 12, 13. Epoch 4 Subcutaneous administration weeks 17, 18

  10. Trough Levels of IgG (Total), and IgG Subclasses at the End of the Treatment Intervals

    Measured: Epoch 1: 3 week IV interval- weeks 0, 1, 4, 7, 10, 13. Epoch 1: 4 week IV interval- weeks 0, 1, 5, 9, 13. Epochs 2 & 3: Subcutaneous (SC) weeks 5, 9. Epoch 4: SC weeks 1, 9, 17, 29, 40 (week dependent on time to establish "Adjusted Dose" in Epoch 2)

  11. Trough Levels of Anti-Tetanus Antibody

    Measured: Epoch 1: 3 week IV interval- weeks 1, 4, 7, 10, 13. Epoch 1: 4 week IV interval- weeks 1, 5, 9, 13. Epochs 2 & 3: Subcutaneous (SC) weeks 5, 9. Epoch 4: SC weeks 1, 9, 17, 29, 40 (week dependent on time to establish "Adjusted Dose" in Epoch 2)

  12. Trough Levels of Anti-Haemophilus Influenza B Antibody

    Measured: Epoch 1: 3 week IV interval- weeks 1, 4, 7, 10, 13. Epoch 1: 4 week IV interval- weeks 1, 5, 9, 13. Epochs 2 & 3: Subcutaneous (SC) weeks 5, 9. Epoch 4: SC weeks 1, 9, 17, 29, 40 (week dependent on time to establish "Adjusted Dose" in Epoch 2)

  13. Trough Levels of Anti-Hepatitis B Antibody

    Measured: Epoch 1: 3 week IV interval- weeks 1, 4, 7, 10, 13. Epoch 1: 4 week IV interval- weeks 1, 5, 9, 13. Epochs 2 & 3: Subcutaneous (SC) weeks 5, 9. Epoch 4: SC weeks 1, 9, 17, 29, 40 (week dependent on time to establish "Adjusted Dose" in Epoch 2)

  14. Pharmacokinetics Parameters for Immunoglobulin G (IgG): Area Under the Curve (AUC)

    The AUC between adjacent infusions will be calculated by the trapezoidal rule. Linear interpolation/extrapolation will be used to calculate the AUC for exact duration of the infusion intervals (21 or 28 days for IV administration and 7 days for SC administration). To allow for comparisons between Epochs 1, 2 and 4, AUC0-τ will be standardized for the infusion intervals (3 or 4 weeks vs. 1 week)

    Measured: Epoch 1: 3 week IV interval: Weeks 10-13. Epoch 1: 4 week IV interval: Weeks 9-13. Epoch 2: Subcutaneous (SC) weeks 9-10. Epoch 4: SC weeks 17-18

  15. Pharmacokinetics Parameters for Immunoglobulin G (IgG): Dose Per Weight-adjusted Area Under the Curve (AUC)

    The AUC between adjacent infusions will be calculated by the trapezoidal rule. Linear interpolation/extrapolation will be used to calculate the AUC for exact duration of the infusion intervals (21 or 28 days for IV administration and 7 days for SC administration). To allow for comparisons between Epochs 1, 2 and 4, AUC0-τ will be standardized for the infusion intervals (3 or 4 weeks vs. 1 week) adjusted for the dose per weight.

    Measured: Epoch 1: 3 week IV interval: Weeks 10-13. Epoch 1: 4 week IV interval: Weeks 9-13. Epoch 2: Subcutaneous (SC) weeks 9-10. Epoch 4: SC weeks 17-18

  16. Pharmacokinetics Parameters for Immunoglobulin G (IgG): Clearance (CL) for Immune Globulin Administered Intravenously (IGIV) and Apparent Clearance for Immune Globulin Administered Subcutaneously (IGSC)

    Clearance (CL) or apparent clearance (CL/F) for IV and SC administration, respectively, will be determined by the formula: CL or CL/F = (Dose (mg/kg)) / (AUC 0-τ). (F= bioavailability)

    Measured: Epoch 1: 3 week IV interval: Weeks 10-13. Epoch 1: 4 week IV interval: Weeks 9-13. Epoch 2: Subcutaneous (SC) weeks 9-10. Epoch 4: SC weeks 17-18

  17. Pharmacokinetics Parameters for Immunoglobulin G (IgG): Maximum Concentration (Cmax)

    The maximum concentration (Cmax) following administration of study drug (either immune globulin administered intravenously (IGIV) or immune globulin administered subcutaneously (IGSC).

    Measured: Epoch 1: 3 week IV interval: Weeks 10-13. Epoch 1: 4 week IV interval: Weeks 9-13. Epoch 2: Subcutaneous (SC) weeks 9-10. Epoch 4: SC weeks 17-18

  18. Pharmacokinetics Parameters for Immunoglobulin G (IgG): Time to Maximum Concentration (Tmax)

    The minimum time (Tmax) to reach the maximum concentration (Cmax)

    Measured: Epoch 1: 3 week IV interval: Weeks 10-13. Epoch 1: 4 week IV interval: Weeks 9-13. Epoch 2: Subcutaneous (SC) weeks 9-10. Epoch 4: SC weeks 17-18

  19. Pharmacokinetics Parameters for Immunoglobulin G (IgG): Minimum Concentration (Cmin)

    The minimum concentration (Cmax) following administration of study drug (either immune globulin administered intravenously (IGIV) or immune globulin administered subcutaneously (IGSC).

    Measured: Epoch 1: 3 week IV interval: Weeks 10-13. Epoch 1: 4 week IV interval: Weeks 9-13. Epoch 2: Subcutaneous (SC) weeks 9-10. Epoch 4: SC weeks 17-18

  20. Pharmacokinetics Parameters for Haemophilus Influenza B Antibody: Area Under the Curve (AUC)

    The AUC between adjacent infusions will be calculated by the trapezoidal rule . Linear interpolation/extrapolation will be used to calculate the AUC for exact duration of the infusion intervals (21 or 28 days for IV administration and 7 days for SC administration). To allow for comparisons between Epochs 1, 2 and 4, AUC 0-τ will be standardized for the infusion intervals (3 or 4 weeks vs. 1 week )

    Measured: Epoch 1: 3 week IV interval: Weeks 10-13. Epoch 1: 4 week IV interval: Weeks 9-13. Epoch 2: Subcutaneous (SC) weeks 9-10. Epoch 4: SC weeks 17-18

  21. Pharmacokinetics Parameters for Haemophilus Influenza B Antibody: Dose Per Weight-adjusted Area Under the Curve (AUC)

    The AUC between adjacent infusions will be calculated by the trapezoidal rule . Linear interpolation/extrapolation will be used to calculate the AUC for exact duration of the infusion intervals (21 or 28 days for IV administration and 7 days for SC administration). To allow for comparisons between Epochs 1, 2 and 4, AUC 0-τ will be standardized for the infusion intervals (3 or 4 weeks vs. 1 week) adjusted for the dose per weight.

    Measured: Epoch 1: 3 week IV interval: Weeks 10-13. Epoch 1: 4 week IV interval: Weeks 9-13. Epoch 2: Subcutaneous (SC) weeks 9-10. Epoch 4: SC weeks 17-18

  22. Pharmacokinetics Parameters for Haemophilus Influenza B Antibody: Clearance (CL) for Immune Globulin Administered Intravenously (IGIV) and Apparent Clearance (CL/F) for Immune Globulin Administered Subcutaneously

    Clearance (CL) or apparent clearance (CL/F) for IV and SC administration, respectively, will be determined by the formula: CL or CL/F = (Dose (mg/kg)) / (AUC 0- τ). (F= bioavailability)

    Measured: Epoch 1: 3 week IV interval: Weeks 10-13. Epoch 1: 4 week IV interval: Weeks 9-13. Epoch 2: Subcutaneous (SC) weeks 9-10. Epoch 4: SC weeks 17-18

  23. Pharmacokinetics Parameters for Haemophilus Influenza B Antibody: Maximum Concentration (Cmax)

    The maximum concentration (Cmax) following administration of study drug (either immune globulin administered intravenously (IGIV) or immune globulin administered subcutaneously (IGSC).

    Measured: Epoch 1: 3 week IV interval: Weeks 10-13. Epoch 1: 4 week IV interval: Weeks 9-13. Epoch 2: Subcutaneous (SC) weeks 9-10. Epoch 4: SC weeks 17-18

  24. Pharmacokinetics Parameters for Haemophilus Influenza B Antibody: Time to Maximum Concentration (Tmax)

    The minimum time (Tmax) to reach the maximum concentration (Cmax)

    Measured: Epoch 1: 3 week IV interval: Weeks 10-13. Epoch 1: 4 week IV interval: Weeks 9-13. Epoch 2: Subcutaneous (SC) weeks 9-10. Epoch 4: SC weeks 17-18

  25. Pharmacokinetics Parameters for Haemophilus Influenza B Antibody: Minimum Concentration (Cmin)

    The minimum concentration (Cmax) following administration of study drug (either immune globulin administered intravenously (IGIV) or immune globulin administered subcutaneously (IGSC).

    Measured: Epoch 1: 3 week IV interval: Weeks 10-13. Epoch 1: 4 week IV interval: Weeks 9-13. Epoch 2: Subcutaneous (SC) weeks 9-10. Epoch 4: SC weeks 17-18

  26. Correction Factor to Determine the Individually Adapted Dose in Study 170904 Epoch 4 (Dose Adjustment Table)

    There is a high degree of variability in catabolism of immunoglobulin G (IgG) between individuals. To address this, trough levels immediately prior to the 9th weekly infusion in Epoch 3 were measured. The ratio of the measured trough levels on subcutaneous (SC) (Epoch 3) and intravenous (IV) administration (Epoch1) were compared to the expected trough level determined in Epoch 2. This was used to determine the Individually Adapted Dose to be used in Epoch 4. This was an interim study analysis.

    Measured: 29 weeks

  27. Number of Serious (SAEs) and Non-serious Adverse Events (AEs) (Including and Excluding Infections) Deemed Related to the Investigational Product Per Participant

    Number of related SAEs and AEs divided by number of participants

    Measured: Up to 20 months per subject (throughout entire study)

  28. Number of Serious (SAEs) and Non-serious Adverse Events (AEs) (Including and Excluding Infections) Deemed Related to the Investigational Product Per Infusion

    Number of related SAEs and AEs divided by number of subjects and divided by number of infusions

    Measured: Up to 20 months per subject (throughout entire study)

  29. Number of Serious (SAEs) and Non-serious Adverse Events (AEs) (Including and Excluding Infections) Regardless of Relationship to the Investigational Product Per Participant

    Number of all SAEs and AEs divided by number of participants

    Measured: Up to 20 months per subject (throughout entire study)

  30. Number of Serious (SAEs) and Non-serious Adverse Events (AEs) (Including and Excluding Infections) Regardless of Relationship to the Investigational Product Per Infusion

    Number of all SAEs and AEs divided by number of infusions

    Measured: Up to 20 months per subject (throughout entire study)

  31. Number of Adverse Events (AEs) (Including and Excluding Infections) That Begin During or Within 72 Hours of Completion of Infusion Per Participant

    Number of AEs that begin during or within 72 hours of completion of infusion divided by number of participants

    Measured: Within 72 hours of completion of infusion

  32. Number of Adverse Events (AEs) (Including and Excluding Infections) That Begin During or Within 72 Hours of Completion of Infusion Per Infusion

    Number of AEs that begin during or within 72 hours of completion of infusion divided by the number of infusions

    Measured: Within 72 hours of completion of infusion

  33. Number of Adverse Events (AEs) (Including and Excluding Infections) That Begin During or Within 24 Hours of Completion of Infusion Per Participant

    Number of AEs that begin during or within 24 hours of completion of infusion divided by number of participants

    Measured: Within 24 hours of completion of infusion

  34. Number of Adverse Events (AEs) (Including and Excluding Infections) That Begin During or Within 24 Hours of Completion of Infusion Per Infusion

    Number of AEs that begin during or within 24 hours of completion of infusion divided by number of infusions

    Measured: Within 24 hours of completion of infusion

  35. Number of Adverse Events (AEs) (Including and Excluding Infections) That Begin During or Within 1 Hour of Completion of Infusion Per Participant

    Number of AEs that begin during or within 1 hour of completion of infusion divided by number of participants

    Measured: Within 1 hour of completion of infusion

  36. Number of Adverse Events (AEs) (Including and Excluding Infections) That Begin During or Within 1 Hour of Completion of Infusion

    Number of AEs that begin during or within 1 hour of completion of infusion divided by number of infusions

    Measured: Within 1 hour of completion of infusion

  37. Causally Related and/or Temporally Associated Adverse Events (AEs) Per Infusion

    The total number of all AEs (including and excluding infections) that begin during infusion or within 72 hours of completion of an infusion ("temporally associated") plus the total number of AEs (including and excluding infections) starting more than 72 hours following the completion of an infusion determined by the investigator to be at least possibly related to the study drug("related"), divided by the total number of infusions

    Measured: Within 72 hours post infusion for Temporally Associated AEs; End of each Study Epoch (Epoch 1, Epoch 2, Epoch 3, and Epoch 4) for Causally Related AEs

  38. Percentage of Infusions Associated With One or More Local Non-serious Adverse Events (Non-SAEs)

    The number of infusions associated with local non-SAEs divided by the total number of infusions.

    Measured: Up to 20 months (throughout entire study)

  39. Percentage of Participants Reporting One or More Local Non-serious Adverse Events (Non-SAEs)

    Measured: Up to 20 months (throughout entire study)

  40. Number of Infusions for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped Due to Tolerability Concerns or AEs

    Measured: Up to 20 months (throughout entire study)

  41. Percentage of Participants for Whom the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped Due to Tolerability Concerns or AEs

    Measured: Up to 20 months (throughout entire study)

  42. Percentage of Infusions Tolerated With Intravenous or Subcutaneous Administration

    An infusion will be deemed as tolerated unless one of the following occurs: 1. Any serious related AE(s) 2. Any non-serious local or systemic related AE(s) that prevent(s) completion of infusion 3. Any severe non-serious local or systemic related AE(s) that occur within 60 minutes of completion of the infusion

    Measured: Up to 20 months (throughout entire study)

  43. Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1

    Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered intravenously (Human), 10% (IV 10%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. *Note 5th Grade (grade 0) added to scale to reflect within normal range.

    Measured: Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion

  44. Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2

    Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered intravenously (Human), 10% (IV 10%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. *Note 5th Grade (grade 0) added to scale to reflect within normal range.

    Measured: Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion

  45. Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3

    Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered intravenously (Human), 10% (IV 10%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. *Note 5th Grade (grade 0) added to scale to reflect within normal range.

    Measured: Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion

  46. Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1

    Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered subcutaneously (Human), 20% (SC 20%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. *Note 5th Grade (grade 0) added to scale to reflect within normal range.

    Measured: Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion

  47. Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2

    Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered subcutaneously (Human), 20% (SC 20%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. *Note 5th Grade (grade 0) added to scale to reflect within normal range.

    Measured: Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion

  48. Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3

    Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered subcutaneously (Human), 20% (SC 20%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. *Note 5th Grade (grade 0) added to scale to reflect within normal range.

    Measured: Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion

  49. Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1

    Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered intravenously (Human), 10% (IV 10%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. *Note 5th Grade (grade 0) added to scale to reflect within normal range.

    Measured: Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion

  50. Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2

    Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered intravenously (Human), 10% (IV 10%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. *Note 5th Grade (grade 0) added to scale to reflect within normal range.

    Measured: Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion

  51. Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3

    Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered intravenously (Human), 10% (IV 10%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. *Note 5th Grade (grade 0) added to scale to reflect within normal range.

    Measured: Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion

  52. Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1

    Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered subcutaneously (Human), 20% (SC 20%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. *Note 5th Grade (grade 0) added to scale to reflect within normal range.

    Measured: Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion

  53. Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2

    Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered subcutaneously (Human), 20% (SC 20%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. *Note 5th Grade (grade 0) added to scale to reflect within normal range.

    Measured: Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion

  54. Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3

    Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered subcutaneously (Human), 20% (SC 20%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. *Note 5th Grade (grade 0) added to scale to reflect within normal range.

    Measured: Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion

  55. Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1

    Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered intravenously (Human), 10% (IV 10%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. *Note 5th Grade (grade 0) added to scale to reflect within normal range.

    Measured: Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion

  56. Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2

    Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered intravenously (Human), 10% (IV 10%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. *Note 5th Grade (grade 0) added to scale to reflect within normal range.

    Measured: Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion

  57. Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3

    Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered intravenously (Human), 10% (IV 10%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. *Note 5th Grade (grade 0) added to scale to reflect within normal range.

    Measured: Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion

  58. Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1

    Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered subcutaneously (Human), 20% (SC 20%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. *Note 5th Grade (grade 0) added to scale to reflect within normal range.

    Measured: Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion

  59. Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2

    Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered subcutaneously (Human), 20% (SC 20%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. *Note 5th Grade (grade 0) added to scale to reflect within normal range.

    Measured: Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion

  60. Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3

    Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered subcutaneously (Human), 20% (SC 20%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. *Note 5th Grade (grade 0) added to scale to reflect within normal range.

    Measured: Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion

  61. Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1

    Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered intravenously (Human), 10% (IV 10%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. *Note 5th Grade (grade 0) added to scale to reflect within normal range.

    Measured: Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion

  62. Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2

    Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered intravenously (Human), 10% (IV 10%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. *Note 5th Grade (grade 0) added to scale to reflect within normal range.

    Measured: Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion

  63. Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3

    Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered intravenously (Human), 10% (IV 10%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. *Note 5th Grade (grade 0) added to scale to reflect within normal range.

    Measured: Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion

  64. Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1

    Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered subcutaneously (Human), 20% (SC 20%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. *Note 5th Grade (grade 0) added to scale to reflect within normal range.

    Measured: Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion

  65. Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2

    Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered subcutaneously (Human), 20% (SC 20%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. *Note 5th Grade (grade 0) added to scale to reflect within normal range.

    Measured: Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion

  66. Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3

    Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered subcutaneously (Human), 20% (SC 20%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. *Note 5th Grade (grade 0) added to scale to reflect within normal range.

    Measured: Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion

  67. Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1

    Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered subcutaneously (Human), 20% (SC 20%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. *Note 5th Grade (grade 0) added to scale to reflect within normal range.

    Measured: Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion

  68. Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2

    Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered intravenously (Human), 10% (IV 10%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. *Note 5th Grade (grade 0) added to scale to reflect within normal range.

    Measured: Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion

  69. Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3

    Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered intravenously (Human), 10% (IV 10%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. *Note 5th Grade (grade 0) added to scale to reflect within normal range.

    Measured: Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion

  70. Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1

    Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered subcutaneously (Human), 20% (SC 20%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. *Note 5th Grade (grade 0) added to scale to reflect within normal range.

    Measured: Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion

  71. Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2

    Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered subcutaneously (Human), 20% (SC 20%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. *Note 5th Grade (grade 0) added to scale to reflect within normal range.

    Measured: Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion

  72. Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3

    Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered subcutaneously (Human), 20% (SC 20%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. *Note 5th Grade (grade 0) added to scale to reflect within normal range.

    Measured: Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion

  73. Number of Participants With Laboratory Confirmed Hemolysis That Occurred Following Investigational Product Administration

    Laboratory tests for confirmation of potential hemolysis include Coomb's test, haptoglobin, free hemoglobin, reticulocyte count, lactate dehydrogenase (LDH), and urine hemosiderin.

    Measured: Epoch 1: 3 week IV interval- weeks 0, 10. Epoch 1: 4 week IV interval- weeks 0, 9. Epoch 3: Subcutaneous (SC) week 9. Epoch 4: SC weeks 17, 18, 40

  74. Quality of Life- Pediatric Quality of Life Inventory^TM (PEDS-QL^TM) (Observer: Parent) for the Age Group 2 to 7 Years

    The Peds-QL is a generic Health-Related Quality of Life (HR QoL) instrument designed specifically for a pediatric population. It captures the following domains: general health/activities, feelings/emotional, social functioning, school functioning. Higher scores indicate better quality of life (QoL) for all domains of the Peds-QL. This modular instrument uses a 5-point scale: from 0 (never) to 4 (almost always). Items are reversed scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, 4=0. 4 dimensions (physical, emotional, social, \& school functioning) are scored. 2 summary scores (Psychosocial Health Summary, and Physical Health Summary) are presented, along with a total score.

    Measured: Up to 20 months (throughout entire study)

  75. Quality of Life- PEDS-QL^TM (Observer: Participant) for the Age Group 8 to 13 Years of Age

    The Peds-QL is a generic Health-Related Quality of Life (HR QoL) instrument designed specifically for a pediatric population. It captures the following domains: general health/activities, feelings/emotional, social functioning, school functioning. Higher scores indicate better quality of life (QoL) for all domains of the Peds-QL. This modular instrument uses a 5-point scale: from 0 (never) to 4 (almost always). Items are reversed scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, 4=0. 4 dimensions (physical, emotional, social, \& school functioning) are scored. 2 summary scores (Psychosocial Health Summary, and Physical Health Summary) are presented, along with a total score.

    Measured: Up to 20 months (throughout entire study)

  76. Quality of Life- Short-Form 36v2 (SF-36v2) for the Age Group 14 Years and Older

    The PCS is a summary scale of the dimensions physical functioning, role physical, bodily pain, and general health. The component score is normalized to a standard population. Scores range from 0 to 100 with higher scores representing better health. There is no total overall score; scoring is done for both sub-scores and summary scores.

    Measured: Up to 20 months (throughout entire study)

  77. Treatment Satisfaction Questionnaire for Medication (TSQM) - 2 to 12 Years Old

    TSQM; for the age group 2 to 12 years the observer will be a parent. Treatment Satisfaction Questionnaire for Medication (TSQM) is a global satisfaction scale used to assess the overall level of participant's satisfaction or dissatisfaction with their medications. The following 3 domain were included: effectiveness, convenience, and global satisfaction. The score of each of the 3 domains is based on an algorithm to create a score of 0 to 100. Higher score indicated greater satisfaction in that domain.

    Measured: Up to 20 months per subject (throughout entire study)

  78. Treatment Satisfaction Questionnaire for Medication (TSQM) - 13 Years and Older

    TSQM; for the age group 13 years and older the observer will be the participant. Treatment Satisfaction Questionnaire for Medication (TSQM) is a global satisfaction scale used to assess the overall level of participant's satisfaction or dissatisfaction with their medications. The following 3 domain were included: effectiveness, convenience, and global satisfaction. The score of each of the 3 domains is based on an algorithm to create a score of 0 to 100. Higher score indicated greater satisfaction in that domain.

    Measured: Up to 20 months per subject (throughout entire study)

  79. Life Quality Index - 2 to 12 Years Old

    For the age group 2 to 12 years the respondent will be a parent. Each of the four domains has a separate score, each has a different range as follows: Treatment Interference Score Range: 6-42, Therapy-related Problems Score Range: 4-28, Therapy Setting Score Range: 3-21, Cost Score Range: 2-14. Higher scores represent more satisfaction with various aspects of treatment.

    Measured: Up to 20 months (throughout entire study)

  80. Life Quality Index - 13 Years and Older

    For the age group 13 years and older the respondent will be the participant. Each of the four domains has a separate score, each has a different range as follows: Treatment Interference Score Range: 6-42, Therapy-related Problems Score Range: 4-28, Therapy Setting Score Range: 3-21, Cost Score Range: 2-14. Higher scores represent more satisfaction with various aspects of treatment.

    Measured: Up to 20 months per subject (throughout entire study)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Oct 2010 (estimated)
  2. Study start28 Jan 2013
  3. Primary completion13 Mar 2015
  4. Study completion13 Mar 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
86 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01218438
Sponsor's protocol ID
170904
Status last verified
Jun 2021
First submitted
8 Oct 2010
Last updated
20 Jul 2021
Data monitoring committee
No
Individual data sharing
Yes: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

Publications

  • Al-Herz W, Bousfiha A, Casanova JL, Chapel H, Conley ME, Cunningham-Rundles C, Etzioni A, Fischer A, Franco JL, Geha RS, Hammarstrom L, Nonoyama S, Notarangelo LD, Ochs HD, Puck JM, Roifman CM, Seger R, Tang ML. Primary immunodeficiency diseases: an update on the classification from the international union of immunological societies expert committee for primary immunodeficiency. Front Immunol. 2011 Nov 8;2:54. doi: 10.3389/fimmu.2011.00054. eCollection 2011.

    PubMed 22566844

  • Conley ME, Notarangelo LD, Etzioni A. Diagnostic criteria for primary immunodeficiencies. Representing PAGID (Pan-American Group for Immunodeficiency) and ESID (European Society for Immunodeficiencies). Clin Immunol. 1999 Dec;93(3):190-7. doi: 10.1006/clim.1999.4799. No abstract available.

    PubMed 10600329

  • Li Z, McCoy B, Engl W, Yel L. Steady-State Serum IgG Trough Levels Are Adequate for Pharmacokinetic Assessment in Patients with Immunodeficiencies Receiving Subcutaneous Immune Globulin. J Clin Immunol. 2021 Aug;41(6):1331-1338. doi: 10.1007/s10875-021-00990-z. Epub 2021 May 26.

    PubMed 34036490

  • Suez D, Krivan G, Jolles S, Stein M, Gupta S, Paris K, van Hagen PM, Brodszki N, Engl W, Leibl H, McCoy B, Yel L. Safety and tolerability of subcutaneous immunoglobulin 20% in primary immunodeficiency diseases from two continents. Immunotherapy. 2019 Aug;11(12):1057-1065. doi: 10.2217/imt-2019-0057. Epub 2019 Jul 3.

    PubMed 31268374

  • Gupta S, Stein M, Hussain I, Paris K, Engl W, McCoy B, Rabbat CJ, Yel L. Tolerability of Ig20Gly during onboarding in patients with primary immunodeficiency diseases. Ann Allergy Asthma Immunol. 2019 Sep;123(3):271-279.e1. doi: 10.1016/j.anai.2019.06.004. Epub 2019 Jun 20.

    PubMed 31228628

  • Paris K, Haddad E, Borte M, Brodszki N, Derfalvi B, Marodi L, Hussain I, Darter A, Engl W, Leibl H, McCoy B, Yel L. Tolerability of subcutaneous immunoglobulin 20%, Ig20Gly, in pediatric patients with primary immunodeficiencies. Immunotherapy. 2019 Apr;11(5):397-406. doi: 10.2217/imt-2018-0088. Epub 2019 Jan 9.

    PubMed 30626238

  • Suez D, Stein M, Gupta S, Hussain I, Melamed I, Paris K, Darter A, Bourgeois C, Fritsch S, Leibl H, McCoy B, Gelmont D, Yel L. Efficacy, Safety, and Pharmacokinetics of a Novel Human Immune Globulin Subcutaneous, 20 % in Patients with Primary Immunodeficiency Diseases in North America. J Clin Immunol. 2016 Oct;36(7):700-12. doi: 10.1007/s10875-016-0327-9. Epub 2016 Aug 31.

    PubMed 27582171

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Immune Globulin Intravenous (Human), 10% Solution and Immune Globulin Subcutaneous (Human), 20% Solution in people with Primary Immunodeficiency Diseases (PID), run by Baxalta now part of Shire at 18 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Feb 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of Acute Serious Bacterial Infections Per Year (ASBI) (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01218438, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2021.

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