Common Variable ImmunodeficiencyNCT00661401
Specific IgG Antibody in Patients With Primary Antibody Deficiencies Treated With Subcutaneous Immunoglobulin
A study testing gammaglobulin in people with Common Variable Immunodeficiency and Agammaglobulinemia, run by Federal University of São Paulo at 1 site in Brazil.
Trial summary
Objective: Measure serum IgG antibody to Streptococcus pneumoniae serotypes 1, 3, 5, 6B, 9V e 14, Haemophilus influenzae type b and tetanus toxoid in patients with primary antibody deficiencies who were treated with subcutaneous immunoglobulin infusions. Read more about this study
- Who is it for?
- Ages 2 to 75 years
- Conditions the study is for
- Common Variable Immunodeficiency, Agammaglobulinemia
- What is being tested?
- gammaglobulin
- Type of treatment
- Injection or infusion
- How many people
- 5 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2002to Nov 2002
- Phase
- Interventional
- 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 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- a diagnosis of a primary immunodeficiency disease with hypo-or agammaglobulinemia
- diagnosis performed according to the WHO definitions
- already been treated with Intravenous immunoglobulin or subcutaneous immunoglobulin for at least 6 months prior to enrollment into this study
- documented IgG trough levels (at least two values), type of used IgG preparation, dosage and dosage interval over a period of 6 months prior to enrollment into this study
Who cannot join
- history of hypersensitivity to the study medication or to drugs with similar chemical structures
- hypersensitivity to IgA
- subjects currently requiring <400 or > 600 mg/kg/b.w. immunoglobulin per month
- subjects whose dosage intervals for IV Ig are < 3 weeks
- know pregnancy or positive pregnancy test
- nursing mothers
Show all 24Show fewer
- childbearing potential, if an acceptable birth control is not practiced
- history of chronic or persisting renal insufficiency (serum creatinine above upper limit of normal)
- history of chronic or persisting hepatic insufficiency (ALT> 2 times the upper limit of normal)
- risk of developing acute renal failure (Diabetes mellitus, volume depletion, sepsis, paraproteinemia)
- any symptomatic heart disease requiring treatment (NYHA class II or above)
- history of seizure disorder
- history or risk for occlusive vascular disease
- indication of active hepatitis A, B, or C at screening (HAV-PCR, HBV-PCR, or HCV-PCR positive)
- detection of HIV-1 PCR positive
- likelihood of requiring treatment during the study period with drugs not permitted by the study protocol
- progressive fatal disease/life expectancy of less than 12 months
- history of drug or alcohol abuse
- pathological mental condition rendering the subject unable to understand, scope and possible consequences of the study and/or evidence of an uncooperative attitude
- treatment with nephrotoxic drugs during the last 3 weeks
- treatment with any other investigational drug in the last 3 months before study entry or likelihood of treatment with another investigational grug during the study period
- evidence of uncooperative attitude
- vaccination against hepatitis B within 3 months before enrollment into the study
- former participation in this trial
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Division of Allergy, Clinical Immunology and Rheumatology, Department of Pediatrics, Federal University of São Paulo
São Paulo, São Paulo, Cep 04025-002
About this study
Official title: Serum IgG Antibody to Streptococcus Pneumoniae, Haemophilus Influenzae Type b and Tetanus Toxoid in Patients With Primary Antibody Deficiencies Treated With Subcutaneous Immunoglobulin Infusions
Objective: Measure serum IgG antibody to Streptococcus pneumoniae serotypes 1, 3, 5, 6B, 9V e 14, Haemophilus influenzae type b and tetanus toxoid in patients with primary antibody deficiencies who were treated with subcutaneous immunoglobulin infusions.
Read the detailed description
Therapy with polyvalent immunoglobulin (Ig) has been established as the standard therapy for antibody deficiencies for several decades now. Although subcutaneous infusions were originally proposed as an alternative to intramuscular injections, more recently, this method has been proven as a safe and convenient method for providing immunoglobulin levels in adults and children. Subcutaneous administration of immunoglobulins has some clinical advantages over intravenous immunoglobulin infusions (IVIG) , including a more benign side effect profile, better sustained levels of IgG in the blood and reduced cost. An additional benefit is an improvement in the quality of life, which is in part secondary to the feasibility of the patients to administer it themselves at home. The most common infections in primary antibody deficiency patients involves encapsulated bacteria, mainly Streptococcus pneumoniae and Haemophilus influenzae type b. The aim of this study is to verify if patients with antibody deficiency receiving subcutaneous immunoglobulin (SCIG) infusions keep protective antibody levels to Streptococcus pneumoniae, Haemophilus influenzae type b (Hib) and tetanus toxoid.
- Being tested
- gammaglobulin
- Keywords
- gammaglobulin, subcutaneous infusion, specific antibodies, primary antibody deficiency
- Medical subject headings
- Common Variable Immunodeficiency, Agammaglobulinemia, Primary Immunodeficiency Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gammaglobulinBiological
Also called Beriglobin 17540311E
They were administered a polyvalent, pasteurized liquid immune globulin subcutaneously (human 16% Beriglobin ®, Germany) with doses ranging from 57 to 132 mg/kg/week in order to maintain the same dosage they received by intravenous route monthly previous to this protocol. After a wash-out period (15 weeks) of the subcutaneous immunoglobulin administration, blood was collected every 4 weeks immediately before infusions. The infusions were administered using battery-powered ambulatory syringe drivers together with 10 or 20 ml syringe and infusions sets according to a pre-defined protocol (Gardulf et al, 2006).
What is being measured
The primary outcome is the main question the study is designed to answer.
Specific IgG levels were measured using ELISA. Adequate response was arbitrarily defined as equal to or higher than 1.3 mg/L to pneumococci (Sorensen RU et al 1998), 1.0 mg/L to Hib (Takano AO 1997) and 0.1 IU/mL to tetanus toxoid (Kayhtyh et al 1983).
Measured: Samples from patients blood was collected every 4 weeks on 7 different occasions immediately before infusions.All patients were treated with subcutaneous immunoglobulin for 43 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2008 (estimated)
- Study startJan 2002
- Primary completionNov 2002
- Study completionNov 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Common Variable ImmunodeficiencyStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- CSL Behring
- Investigators
- Beatriz T Costa Carvalho, md PhD, Study director, Federal University of São PauloCharles K Naspitz, md MSc, Study chair, Federal University of São PauloAlbertina RB Pizzamiglio, md MSc, Principal investigator, Federal University of São PauloAparecida T Nagao-Dias, Study director, Federal University of Ceará
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00661401
- Sponsor's protocol ID
- 310570
- Other IDs
- 315970
- Status last verified
- Apr 2008
- First submitted
- 14 Apr 2008
- Last updated
- 18 Apr 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Gardulf A, Nicolay U, Asensio O, Bernatowska E, Bock A, Carvalho BC, Granert C, Haag S, Hernandez D, Kiessling P, Kus J, Pons J, Niehues T, Schmidt S, Schulze I, Borte M. Rapid subcutaneous IgG replacement therapy is effective and safe in children and adults with primary immunodeficiencies--a prospective, multi-national study. J Clin Immunol. 2006 Mar;26(2):177-85. doi: 10.1007/s10875-006-9002-x. Epub 2006 Apr 26.
PubMed 16758340Sorensen RU, Leiva LE, Javier FC 3rd, Sacerdote DM, Bradford N, Butler B, Giangrosso PA, Moore C. Influence of age on the response to Streptococcus pneumoniae vaccine in patients with recurrent infections and normal immunoglobulin concentrations. J Allergy Clin Immunol. 1998 Aug;102(2):215-21. doi: 10.1016/s0091-6749(98)70089-2.
PubMed 9723664Kayhty H, Peltola H, Karanko V, Makela PH. The protective level of serum antibodies to the capsular polysaccharide of Haemophilus influenzae type b. J Infect Dis. 1983 Jun;147(6):1100. doi: 10.1093/infdis/147.6.1100. No abstract available.
PubMed 6602191Pichichero ME, Anderson EL, Rennels MB, Edwards KM, England JA. Fifth vaccination with dipthteria, tetanus and acellular pertussis is beneficial in four- to six-year-olds. Pediatr Infect Dis J. 2001 Apr;20(4):427-33. doi: 10.1097/00006454-200104000-00011.
PubMed 11332669
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serum IgG Antibody to Streptococcus Pneumoniae, Haemophilus Influenzae Type b and Tetanus Toxoid in Patients With Primary Antibody Deficiencies Treated With Subcutaneous Immunoglobulin Infusions
- ClinicalTrials.gov ID
- NCT00661401
- Acronym / sponsor ID
- 310570
- Keywords
- gammaglobulin, subcutaneous infusion, specific antibodies, primary antibody deficiency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Collaborators
- CSL Behring
- Study start
- Jan 2002
- Primary completion
- Nov 2002 (actual)
- Study completion
- Nov 2002 (actual)
- First posted
- 18 Apr 2008 (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.
Objective: Measure serum IgG antibody to Streptococcus pneumoniae serotypes 1, 3, 5, 6B, 9V e 14, Haemophilus influenzae type b and tetanus toxoid in patients with primary antibody deficiencies who were treated with subcutaneous immunoglobulin infusions.
Detailed description
Therapy with polyvalent immunoglobulin (Ig) has been established as the standard therapy for antibody deficiencies for several decades now. Although subcutaneous infusions were originally proposed as an alternative to intramuscular injections, more recently, this method has been proven as a safe and convenient method for providing immunoglobulin levels in adults and children. Subcutaneous administration of immunoglobulins has some clinical advantages over intravenous immunoglobulin infusions (IVIG) , including a more benign side effect profile, better sustained levels of IgG in the blood and reduced cost. An additional benefit is an improvement in the quality of life, which is in part secondary to the feasibility of the patients to administer it themselves at home. The most common infections in primary antibody deficiency patients involves encapsulated bacteria, mainly Streptococcus pneumoniae and Haemophilus influenzae type b. The aim of this study is to verify if patients with antibody deficiency receiving subcutaneous immunoglobulin (SCIG) infusions keep protective antibody levels to Streptococcus pneumoniae, Haemophilus influenzae type b (Hib) and tetanus toxoid.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 2 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- a diagnosis of a primary immunodeficiency disease with hypo-or agammaglobulinemia
- diagnosis performed according to the WHO definitions
- already been treated with Intravenous immunoglobulin or subcutaneous immunoglobulin for at least 6 months prior to enrollment into this study
- documented IgG trough levels (at least two values), type of used IgG preparation, dosage and dosage interval over a period of 6 months prior to enrollment into this study
Key exclusion criteria (24 listed)
- history of hypersensitivity to the study medication or to drugs with similar chemical structures
- hypersensitivity to IgA
- subjects currently requiring <400 or > 600 mg/kg/b.w. immunoglobulin per month
- subjects whose dosage intervals for IV Ig are < 3 weeks
- know pregnancy or positive pregnancy test
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 |
|---|---|---|
| gammaglobulinAlso: Beriglobin 17540311EThey were administered a polyvalent, pasteurized liquid immune globulin subcutaneously (human 16% Beriglobin ®, Germany) with doses ranging from 57 to 132 mg/kg/week in order to maintain the same dosage they received by intravenous route monthly previous to this protocol. After a wash-out period (15 weeks) of the subcutaneous immunoglobulin administration, blood was collected every 4 weeks immediately before infusions. The infusions were administered using battery-powered ambulatory syringe drivers together with 10 or 20 ml syringe and infusions sets according to a pre-defined protocol (Gardulf et al, 2006). | Biological | – |
Primary outcome
Specific IgG levels were measured using ELISA. Adequate response was arbitrarily defined as equal to or higher than 1.3 mg/L to pneumococci (Sorensen RU et al 1998), 1.0 mg/L to Hib (Takano AO 1997) and 0.1 IU/mL to tetanus toxoid (Kayhtyh et al 1983).
Time frame: Samples from patients blood was collected every 4 weeks on 7 different occasions immediately before infusions.All patients were treated with subcutaneous immunoglobulin for 43 weeks.
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 18 Apr 2008.
- Background: PubMed 16758340Gardulf A, Nicolay U, Asensio O, Bernatowska E, Bock A, Carvalho BC, Granert C, Haag S, Hernandez D, Kiessling P, Kus J, Pons J, Niehues T, Schmidt S, Schulze I, Borte M. Rapid subcutaneous IgG replacement therapy is effective and safe in children and adults with primary immunodeficiencies--a prospective, multi-national study. J Clin Immunol. 2006 Mar;26(2):177-85. doi: 10.1007/s10875-006-9002-x. Epub 2006 Apr 26.
- Background: PubMed 9723664Sorensen RU, Leiva LE, Javier FC 3rd, Sacerdote DM, Bradford N, Butler B, Giangrosso PA, Moore C. Influence of age on the response to Streptococcus pneumoniae vaccine in patients with recurrent infections and normal immunoglobulin concentrations. J Allergy Clin Immunol. 1998 Aug;102(2):215-21. doi: 10.1016/s0091-6749(98)70089-2.
- Background: PubMed 6602191Kayhty H, Peltola H, Karanko V, Makela PH. The protective level of serum antibodies to the capsular polysaccharide of Haemophilus influenzae type b. J Infect Dis. 1983 Jun;147(6):1100. doi: 10.1093/infdis/147.6.1100. No abstract available.
- Background: PubMed 11332669Pichichero ME, Anderson EL, Rennels MB, Edwards KM, England JA. Fifth vaccination with dipthteria, tetanus and acellular pertussis is beneficial in four- to six-year-olds. Pediatr Infect Dis J. 2001 Apr;20(4):427-33. doi: 10.1097/00006454-200104000-00011.
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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.
Beatriz T Costa Carvalho, md PhD study director
Federal University of São Paulo
Charles K Naspitz, md MSc study chair
Federal University of São Paulo
Albertina RB Pizzamiglio, md MSc principal investigator
Federal University of São Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing gammaglobulin in people with Common Variable Immunodeficiency and Agammaglobulinemia, run by Federal University of São Paulo at 1 site in Brazil.
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 4 inclusion and 24 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 18 Apr 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. 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.
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?
Specific IgG levels were measured using ELISA. Adequate response was arbitrarily defined as equal to or higher than 1.3 mg/L to pneumococci (Sorensen RU et al 1998), 1.0 mg/L to Hib (Takano AO 1997) and 0.1 IU/mL to tetanus toxoid (Kayhtyh et al 1983). (time frame: Samples from patients blood was collected every 4 weeks on 7 different occasions immediately before infusions.All patients were treated with subcutaneous immunoglobulin for 43 weeks.). 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 NCT00661401, which also lists 4 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 18 Apr 2008.