NCT01289847

A Study to Find Out How Safe and Effective Gammaplex® is in Young People With Primary Immunodeficiency

A Phase IV, Multicenter, Open-Label Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Gammaplex in Primary Immunodeficiency Diseases (PID) in Children and Adolescents

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Bio Products Laboratory · Academic / Other
• Sex: All
• Age: 2 Years – 16 Years
• Healthy volunteers: Not accepted

Summary

The main objective is to determine the efficacy of Gammaplex by measuring the number of serious acute bacterial infections during treatment with Gammaplex over a 12 month period. The secondary objectives are to assess the safety and tolerability of Gammaplex and to compare the data collected from adult subjects with PID from the GMX01 study

Conditions

• Primary Immune Deficiency Disorders
• Common Variable Immunodeficiency
• X-linked Agammaglobulinemia
• Hyper-IgM Syndrome
• Wiskott-Aldrich Syndrome

Interventions

Type	Name	Description
BIOLOGICAL	Gammaplex	GAMMAPLEX 5g/100 mL, dose is 300-800 mg/kg/infusion every 21 or 28 days, intravenously. The total duration of treatment with GAMMAPLEX will be 12 months with a 3 month follow-up.

Timeline

• Start date: 2011-03-01
• Primary completion: 2014-04-01
• Completion: 2014-04-01
• First posted: 2011-02-04
• Last updated: 2014-12-23
• Results posted: 2014-12-23

Locations

10 sites across 3 countries: United States, Chile, Israel