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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00661401 |
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Date of registration:
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14/04/2008 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Specific IgG Antibody in Patients With Primary Antibody Deficiencies Treated With Subcutaneous Immunoglobulin
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Scientific title:
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Serum IgG Antibody to Streptococcus Pneumoniae, Haemophilus Influenzae Type b and Tetanus Toxoid in Patients With Primary Antibody Deficiencies Treated With Subcutaneous Immunoglobulin Infusions |
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Date of first enrolment:
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January 2002 |
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Target sample size:
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5 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00661401 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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N/A
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Countries of recruitment
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Brazil
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Contacts
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Name:
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Albertina RB Pizzamiglio, md MSc |
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Address:
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Telephone:
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Email:
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Affiliation:
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Federal University of São Paulo |
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Name:
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Aparecida T Nagao-Dias |
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Address:
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Telephone:
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Email:
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Affiliation:
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Federal University of Ceará |
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Name:
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Beatriz T Costa Carvalho, md PhD |
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Address:
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Email:
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Affiliation:
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Federal University of São Paulo |
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Name:
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Charles K Naspitz, md MSc |
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Address:
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Telephone:
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Email:
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Affiliation:
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Federal University of São Paulo |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 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 Criteria:
- 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
Age minimum:
2 Years
Age maximum:
75 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Common Variable Immunodeficiency
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Agammaglobulinemia
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Intervention(s)
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Biological: gammaglobulin
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Primary Outcome(s)
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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.]
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Secondary ID(s)
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310570
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315970
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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