Immunologic Deficiency SyndromePhase 3NCT01406470
Phase 3 Study of Immune Globulin Intravenous (Human)IVIG-SN™ in Subjects With Primary Immunodeficiency
A Phase 3 study testing Immune Globulin Intravenous (Human) 5% Liquid, IVIG-SN™ in people with Immunologic Deficiency Syndrome, run by Green Cross Corporation at 11 sites in 2 countries.
Trial summary
The purpose of this study is to evaluate the safety, efficacy and pharmacokinetics of Immune Globulin Intravenous (Human) IVIG-SN™ in subjects with primary immunodeficiency diseases. Read more about this study
- Who is it for?
- Ages 2 to 70 years
- Conditions the study is for
- Immunologic Deficiency Syndrome
- What is being tested?
- Immune Globulin Intravenous (Human) 5% Liquid, IVIG-SN™
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 11 sitesin 2 countries
- Study dates
- Sep 2011to Jul 2013
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Subjects with a confirmed clinical diagnosis of a Primary Immunodeficiency Disease as defined by IUIS (International Union of Immunological Societies) and require treatment with IVIG. Documented agammaglobulinemia or hypogammaglobulinemia (preferably with documented antibody deficiency).
- Male or female, ages 2 to 70 years.
- The subject has received 300-900 mg/kg of a licensed IGIV therapy at 21 or 28 day intervals for at least 3 months prior to this study.
- At least 2 documented IgG trough levels of ≥ 5 g/L are obtained at two infusion cycles (21 or 28 days) within 12 months prior to study enrollment.
- Subject is willing to comply with all requirements of the protocol.
- Females of child-bearing potential with a negative urine pregnancy test and who agree to employ adequate birth control measures during the study.
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- Subject, parent or guardian has signed the informed consent form and a child assent form if appropriate. Pediatric subjects are defined as 2-17 years of age at study entry and will require assent forms as appropriate per study documentation and regulations of the local jurisdiction.
- Authorization to access personal health information.
- Subjects currently participating in a clinical trial with another experimental IVIG may be enrolled if they have received stable IVIG therapy for at least 3 infusion cycles prior to receiving IVIG-SN™ and all inclusion and exclusion criteria are satisfied. Other IVIGs will be prohibited between the first infusion of IVIG-SN™ and Follow Up Visit 1.
- Subjects currently participating in a trial of SCIG can be enrolled if they are switched to IVIG for three infusion cycles (21 or 28 days) prior to enrollment in this study.
Who cannot join
- Subject has secondary immunodeficiency.
- Subject was newly diagnosed and has not been treated with immunoglobulin or has been diagnosed with dysgammaglobulinemia or isolated IgG subclass deficiency.
- Subject has a history of repeated reactions or hypersensitivity to IVIG or other injectable forms of IgG.
- Subject has a history of thrombotic events including deep vein thrombosis, cerebrovascular accident, pulmonary embolism or transient ischemic attacks, or myocardial infarction, as defined by at least 1 event in subject's lifetime.
- Subject has IgA deficiency and is known to have antibodies to IgA.
- Subject has received blood products other than human albumin or human immunoglobulin within 12 months prior to enrollment.
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- Subject has significant protein losing enteropathy, nephrotic syndrome or lymphangiectasia.
- Subject has an acute infection as documented by culture or diagnostic imaging and/or a body temperature exceeding 38.5 °C (101.3 °F) within 7 days prior to screening
- Subject has a known history or is positive at enrollment for human immunodeficiency virus (HIV) type 1/2 by NAT or hepatitis B virus (HBsAg and NAT) or hepatitis C virus (by NAT), or hepatitis A virus (by NAT).
- Subject has levels of alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2.5 times of the upper limit of normal for the laboratory designated for the study.
- Subject is using an implanted venous access device
- Subject has profound anemia or persistent severe neutropenia (≤ 1000 neutrophils per mm3).
- Subject has a severe chronic condition such as renal failure (creatinine concentration > 2.0 times the upper limit of normal) with proteinuria, congestive heart failure (New York Heart Association III/IV), cardiomyopathy, cardiac arrhythmia associated with thromboembolic events (e.g. atrial fibrillation), unstable or advanced ischemic heart disease, or hyperviscosity, or any other condition that the investigator believes is likely to interfere with evaluation of the study drug or with satisfactory conduct of the trial.
- Subject has a history of a malignant disease other than properly treated carcinoma in situ of the cervix or basal cell or squamous cell carcinoma of the skin within 24 months prior to enrollment.
- Subject has history of epilepsy or multiple episodes of migraine not completely controlled by medication.
- Subject is receiving the following medication:
- Steroids (oral or parenteral daily dose of ≥ 0.15 mg/kg/day of prednisone or equivalent).
- Other immunosuppressive drugs or chemotherapy.
- Females who are pregnant, breast feeding or planning a pregnancy during the course of the study. Women who become pregnant during the study will be withdrawn from the study.
- Subject has participated in another clinical study within 3 weeks prior to study enrollment.
Trial locations and contacts
11 sites in 2 countries.
11 sites in 2 countries
United States9 sites
Bellingham Asthma, Allergy & Immunology Clinic
Bellingham, Washington, 98225
University of Alabama Hospital
Birmingham, Alabama, 35233
Rush University Medical Center
Chicago, Illinois, 33408
Optimed Research, LTD
Columbus, Ohio, 43235
Dallas Allergy Immunology
Dallas, Texas, 75230
AARA Research Center
Dallas, Texas, 75231
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
Allergy Associates of the Palm Beaches
North Palm Beach, Florida, 33408
Children's Hospital of Richmond
Richmond, Virginia, 23219
Canada2 sites
Gordon Sussman Clinical Research Inc.
Toronto, Ontario, M4V1R2
The Hospital for Sick Children
Toronto, Ontario, M5G1X8
About this study
Official title: An Open-Label, Single-Arm, Historically Controlled, Prospective, Multicenter Phase III Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Immune Globulin Intravenous (Human) IVIG-SN™ in Subjects With Primary Immunodeficiency
The purpose of this study is to evaluate the safety, efficacy and pharmacokinetics of Immune Globulin Intravenous (Human) IVIG-SN™ in subjects with primary immunodeficiency diseases.
Read the detailed description
This is an open-label, single-arm, historically controlled, prospective, multicenter phase III study to evaluate the safety, efficacy and pharmacokinetics of Immune Globulin Intravenous (Human) IVIG-SN™ in subjects with primary immunodeficiency diseases.
Subject will be infused every 21 to 28 days according to their previous IVIG treatment schedule. Subjects treated every 28 days will receive 13 study IVIG infusions. Subject treated every 21 days will receive 17 study IVIG infusions.
Duration of treatment:The total duration of treatment is 12 months.
- Conditions
- Immunologic Deficiency Syndrome
- Being tested
- Immune Globulin Intravenous (Human) 5% Liquid, IVIG-SN™
- Keywords
- IGIV, Primary Immune Deficiency, Immunoglobulin G
- Medical subject headings
- Immunologic Deficiency Syndromes, 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) 5% Liquid, IVIG-SN™Drug
Also called IGIV, Immune Globulin Intravenous (Human) 5% Liquid
IVIG-SN™ 10g/200mL, dose is 300-900 mg/kg/infusion every 21 or 28 days, intravenously. The total duration of treatment with IVIG-SN™ will be 12 months with a 3 month follow-up.
| Study group | Role | What they receive |
|---|---|---|
| IVIG-SN™ | Experimental | Immune Globulin Intravenous (Human) 5% Liquid Receives: Drug: Immune Globulin Intravenous (Human) 5% Liquid, IVIG-SN™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of acute serious bacterial infections
Measured: one year
Overall incidence of adverse events that occur during or within 1 hour, 24 hours and 72 hours following an infusion of test product
Measured: Within 72 hours after treatment with IVIG-SN
The Pharmacokinetic (PK) Area under the curve (AUC0-t, AUC0-inf) of Immunoglobulin G (IgG).
Measured: After 5th infusion
The Pharmacokinetic (PK) Maximum concentration (Cmax) of Immunoglobulin G (IgG).
Measured: After 5th infusion
Secondary outcomes (10)
The number of days missed work/school/kindergarten/day care or unable to perform normal daily activities due to infection.
Measured: one year
Days of unscheduled physician visits and hospitalizations due to infection
Measured: One year
Number of days on therapeutic antibiotics
Measured: One year
The incidence of infections other than acute serious bacterial infections
Measured: One year
Annual rate of fever episodes per patient
Measured: One year
All adverse events regardless of causality assessment by investigator
Measured: One year
The proportion and number of IGIV infusions for which the infusion rate was decreased due to adverse events
Measured: One year
The proportion of adverse events considered by the investigator to be product related
Measured: One year
To monitor viral safety (freedom from transmission of blood borne virus diseases)
Measured: One year
Descriptive analyses of PK parameters for specific antibodies (anti-Hemophilus influenza type b, anti-Streptococcus pneumonia serotypes, anti-Tetanus toxoid, anti-cytomegalovirus (CMV), anti-measles) will be performed.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2011 (estimated)
- Study startSep 2011
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immunologic Deficiency SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Green Cross Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Atlantic Research Group
- Responsible party
- Sponsor
- Investigators
- Chaim Roifman, MD, Study chair, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01406470
- Sponsor's protocol ID
- IVIG_SN_P3
- Other IDs
- IVIG_SN_P3
- Status last verified
- Jan 2014
- First submitted
- 26 Jul 2011
- Last updated
- 10 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Single-Arm, Historically Controlled, Prospective, Multicenter Phase III Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Immune Globulin Intravenous (Human) IVIG-SN™ in Subjects With Primary Immunodeficiency
- ClinicalTrials.gov ID
- NCT01406470
- Acronym / sponsor ID
- IVIG_SN_P3
- Conditions
- Immunologic Deficiency Syndrome
- Keywords
- IGIV, Primary Immune Deficiency, Immunoglobulin G
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Green Cross CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Atlantic Research Group
- Study start
- Sep 2011
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 1 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety, efficacy and pharmacokinetics of Immune Globulin Intravenous (Human) IVIG-SN™ in subjects with primary immunodeficiency diseases.
Detailed description
This is an open-label, single-arm, historically controlled, prospective, multicenter phase III study to evaluate the safety, efficacy and pharmacokinetics of Immune Globulin Intravenous (Human) IVIG-SN™ in subjects with primary immunodeficiency diseases.
Subject will be infused every 21 to 28 days according to their previous IVIG treatment schedule. Subjects treated every 28 days will receive 13 study IVIG infusions. Subject treated every 21 days will receive 17 study IVIG infusions.
Duration of treatment:The total duration of treatment is 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IVIG-SN™ | Experimental | Drug: Immune Globulin Intravenous (Human) 5% Liquid, IVIG-SN™Immune Globulin Intravenous (Human) 5% Liquid |
Who may qualify
- Ages
- 2 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- Subjects with a confirmed clinical diagnosis of a Primary Immunodeficiency Disease as defined by IUIS (International Union of Immunological Societies) and require treatment with IVIG. Documented agammaglobulinemia or hypogammaglobulinemia (preferably with documented antibody deficiency).
- Male or female, ages 2 to 70 years.
- The subject has received 300-900 mg/kg of a licensed IGIV therapy at 21 or 28 day intervals for at least 3 months prior to this study.
- At least 2 documented IgG trough levels of ≥ 5 g/L are obtained at two infusion cycles (21 or 28 days) within 12 months prior to study enrollment.
- Subject is willing to comply with all requirements of the protocol.
Key exclusion criteria (20 listed)
- Subject has secondary immunodeficiency.
- Subject was newly diagnosed and has not been treated with immunoglobulin or has been diagnosed with dysgammaglobulinemia or isolated IgG subclass deficiency.
- Subject has a history of repeated reactions or hypersensitivity to IVIG or other injectable forms of IgG.
- Subject has a history of thrombotic events including deep vein thrombosis, cerebrovascular accident, pulmonary embolism or transient ischemic attacks, or myocardial infarction, as defined by at least 1 event in subject's lifetime.
- Subject has IgA deficiency and is known to have antibodies to IgA.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immune Globulin Intravenous (Human) 5% Liquid, IVIG-SN™Also: IGIV, Immune Globulin Intravenous (Human) 5% LiquidIVIG-SN™ 10g/200mL, dose is 300-900 mg/kg/infusion every 21 or 28 days, intravenously. The total duration of treatment with IVIG-SN™ will be 12 months with a 3 month follow-up. | Drug | IVIG-SN™ |
Primary outcome
Incidence of acute serious bacterial infections
Time frame: one year
Overall incidence of adverse events that occur during or within 1 hour, 24 hours and 72 hours following an infusion of test product
Time frame: Within 72 hours after treatment with IVIG-SN
The Pharmacokinetic (PK) Area under the curve (AUC0-t, AUC0-inf) of Immunoglobulin G (IgG).
Time frame: After 5th infusion
The Pharmacokinetic (PK) Maximum concentration (Cmax) of Immunoglobulin G (IgG).
Time frame: After 5th infusion
10 secondary outcomes
The number of days missed work/school/kindergarten/day care or unable to perform normal daily activities due to infection.
Time frame: one year
Days of unscheduled physician visits and hospitalizations due to infection
Time frame: One year
Number of days on therapeutic antibiotics
Time frame: One year
The incidence of infections other than acute serious bacterial infections
Time frame: One year
Annual rate of fever episodes per patient
Time frame: One year
All adverse events regardless of causality assessment by investigator
Time frame: One year
The proportion and number of IGIV infusions for which the infusion rate was decreased due to adverse events
Time frame: One year
The proportion of adverse events considered by the investigator to be product related
Time frame: One year
To monitor viral safety (freedom from transmission of blood borne virus diseases)
Time frame: One year
Descriptive analyses of PK parameters for specific antibodies (anti-Hemophilus influenza type b, anti-Streptococcus pneumonia serotypes, anti-Tetanus toxoid, anti-cytomegalovirus (CMV), anti-measles) will be performed.
Time frame: One year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chaim Roifman, MD study chair
The Hospital for Sick Children
11 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Immune Globulin Intravenous (Human) 5% Liquid, IVIG-SN™ in people with Immunologic Deficiency Syndrome, run by Green Cross Corporation at 11 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?
The sponsor lists 10 inclusion and 20 exclusion criteria. 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 10 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 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 phase mean?
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence of acute serious bacterial infections (time frame: one year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Jan 2014.