At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 24 enrolled
Drug / intervention
Flebogamma 5% DIFbiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Evaluation of the Efficacy and Safety of Flebogamma 5% DIF [Immune Globulin Intravenous (Human)] for Replacement Therapy in Pediatric Subjects With Primary Immunodeficiency Diseases.
In Brief
A Phase 4 clinical trial evaluating Flebogamma 5% DIF for Primary Immune Deficiency Disease. Completed, enrolled 24 participants across 7 sites.
Detailed Summary
This is a multi-center, open-label study to assess the efficacy and safety of Flebogamma 5% DIF in the pediatric population.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPrimary Immune Deficiency Disease
CountriesUnited States
Collaborators--
Timeline
Phase 4CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 2008
Enrollment StartMay 2008
Primary CompletionMar 2011
Study CompletionMay 2011
TodayJul 2026
First PostedMar 13, 2008
Enrollment StartMay 1, 2008
Primary CompletionMar 1, 2011
Study CompletionMay 1, 2011
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 18.3 years ago
Interventions
Flebogamma 5% DIFbiological
Intravenous Immune Globulin (Human)