drugset / Trial / NCT01289847

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

NCT01289847

Phase 4 Completed 25 enrolled Bio Products Laboratory
NaSingle-groupOpen-labelPrevention

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

Timeline

Start
2011-03
Primary completion
2014-04
Completion
2014-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Immune Globulin Intravenous (Human) Protein / enzyme biologic 300 mg/kg Intravenous
Subject Immune Globulin Intravenous (Human) Protein / enzyme biologic 800 mg/kg Intravenous