Status:
COMPLETED
Specific IgG Antibody in Patients With Primary Antibody Deficiencies Treated With Subcutaneous Immunoglobulin
Lead Sponsor:
Federal University of São Paulo
Collaborating Sponsors:
CSL Behring
Conditions:
Common Variable Immunodeficiency
Agammaglobulinemia
Eligibility:
All Genders
2-75 years
Phase:
NA
Brief 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 we...
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2002
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT00661401
Start Date
January 1 2002
End Date
November 1 2002
Last Update
April 18 2008
Active Locations (1)
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1
Division of Allergy, Clinical Immunology and Rheumatology, Department of Pediatrics, Federal University of São Paulo
São Paulo, São Paulo, Brazil, Cep 04025-002