CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 25 enrolled
Drug / intervention
Gammaplexbiological
Likely dose
Gammaplex 5gfrom 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.

Search/NCT01289847
NCT01289847Phase 4Completed
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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

Bio Products Laboratory·interventional·Posted Feb 4, 2011·Updated Dec 23, 2014

In Brief

A Phase 4 clinical trial evaluating Gammaplex for Primary Immune Deficiency Disorders and 4 related conditions. Completed, enrolled 25 participants across 10 sites in 3 countries.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPrimary Immune Deficiency Disorders, Common Variable Immunodeficiency, X-linked Agammaglobulinemia, Hyper-IgM Syndrome, Wiskott-Aldrich Syndrome
CountriesChile, Israel, United States
Collaborators--

Timeline

Phase 4CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 4, 2011
Enrollment StartMar 1, 2011
Primary CompletionApr 1, 2014
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 15.4 years ago

Interventions

Gammaplexbiological

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.