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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: |
NCT00168012 |
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Date of registration:
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12/09/2005 |
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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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Efficacy and Safety of Intravenous Immunoglobulin IVIG-F10 in Patients With Primary Immunodeficiencies (PID)
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Scientific title:
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An Open Study to Evaluate the Safety and Efficacy of IVIG-F10 in Patients With Primary Immunodeficiency Diseases (PID) |
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Date of first enrolment:
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September 2004 |
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Target sample size:
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42 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00168012 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 3
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Key inclusion & exclusion criteria
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Key Inclusion Criteria:
- Patients with primary immunodeficiency
- Regular IVIG therapy for at least 6 months prior to receiving IVIG-F10
Key Exclusion Criteria:
- Allergic reactions to immunoglobulins or other blood products
- Steroids (oral and parenteral, daily =0.15 mg of prednisone equivalent/kg/day
- History of cardiac insufficiency
- Epilepsia
Age minimum:
3 Years
Age maximum:
70 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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IgG Deficiency
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Common Variable Immunodeficiency
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Agammaglobulinemia
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Intervention(s)
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Drug: Immunoglobulins Intravenous (Human)
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Primary Outcome(s)
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Proportion of infusions temporally (during the infusion and within 48 hours after the end of infusion) associated with one or more adverse events, regardless of relationship.
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Secondary Outcome(s)
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Number of infections
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Rate of acute serious bacterial infections
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Rate, severity and relationship of all adverse events
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Number of days out of work/school due to underlying PID
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Secondary ID(s)
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ZLB04_005CR
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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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