Safety and Efficacy Study of Flebogamma 5% DIF IGIV in Pediatric Subjects
Public ClinicalTrials.gov record NCT00634569. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Evaluation of the Efficacy and Safety of Flebogamma 5% DIF [Immune Globulin Intravenous (Human)] for Replacement Therapy in Pediatric Subjects With Primary Immunodeficiency Diseases.
Study identification
- NCT ID
- NCT00634569
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 4
- Lead sponsor
- Instituto Grifols, S.A.
- Industry
- Enrollment
- 24 participants
Conditions and interventions
Conditions
Interventions
- Flebogamma 5% DIF Biological
Biological
Eligibility (public fields only)
- Age range
- 2 Years to 16 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 30, 2008
- Primary completion
- Feb 28, 2011
- Completion
- Apr 30, 2011
- Last update posted
- Feb 1, 2017
2008 – 2011
United States locations
- U.S. sites
- 7
- U.S. states
- 7
- U.S. cities
- 7
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of South Florida | St. Petersburg | Florida | 33701-4899 | — |
| Family Allergy & Asthma Center, PC | Atlanta | Georgia | 30342 | — |
| Rush University Medical Center | Chicago | Illinois | — | — |
| The Allergy and Asthma Center | Fort Wayne | Indiana | 46804 | — |
| The Children's Hospital of Buffalo | Buffalo | New York | 14222 | — |
| Pennsylvania State University, Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033-0850 | — |
| Children's Hospital and Regional Medial Center | Seattle | Washington | 98195-7110 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00634569, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 1, 2017 · Synced May 20, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00634569 live on ClinicalTrials.gov.