NCT00634569

Safety and Efficacy Study of Flebogamma 5% DIF IGIV in Pediatric Subjects

Evaluation of the Efficacy and Safety of Flebogamma 5% DIF [Immune Globulin Intravenous (Human)] for Replacement Therapy in Pediatric Subjects With Primary Immunodeficiency Diseases.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Instituto Grifols, S.A. · Industry
• Sex: All
• Age: 2 Years – 16 Years
• Healthy volunteers: Not accepted

Summary

This is a multi-center, open-label study to assess the efficacy and safety of Flebogamma 5% DIF in the pediatric population.

Conditions

• Primary Immune Deficiency Disease

Interventions

Type	Name	Description
BIOLOGICAL	Flebogamma 5% DIF	Intravenous Immune Globulin (Human)

Timeline

• Start date: 2008-05-01
• Primary completion: 2011-03-01
• Completion: 2011-05-01
• First posted: 2008-03-13
• Last updated: 2017-02-02
• Results posted: 2016-12-08

Locations

7 sites across 1 country: United States