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

Common Variable Immunodeficiency Clinical Trial

Official title:
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

Clinical Trial 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

Clinical Trial Description

n/a

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01289847
Study type Interventional
Source Bio Products Laboratory
Contact
Status Completed
Phase Phase 4
Start date March 2011
Completion date April 2014
View Details
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