CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 12 enrolled
Drug / intervention
GAMUNEX-C +1 morebiological
Likely dose
GAMUNEX-C 600 mg/kgfrom 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/NCT01465958
NCT01465958Phase 4Completed
CompareCT.gov

An Open-label, Single-sequence, Crossover Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Subcutaneous GAMUNEX®-C in Pediatric Subjects With Primary Immunodeficiency

Grifols Therapeutics LLC·interventional·Posted Nov 7, 2011·Updated Mar 13, 2015

In Brief

A Phase 4 clinical trial evaluating GAMUNEX-C for Primary Immunodeficiency. Completed, enrolled 12 participants across 4 sites.

Detailed Summary

The purpose of this open-label study is to evaluate the pharmacokinetics, safety, and tolerability of subcutaneously (SC; under the skin) administered GAMUNEX-C compared to intravenously (IV; through the vein) administered GAMUNEX-C in subjects 2-16 years of age with Primary Immunodeficiency.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPrimary Immunodeficiency
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedNov 7, 2011
Enrollment StartNov 1, 2011
Primary CompletionOct 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 14.7 years ago

Interventions

GAMUNEX-Cbiological

GAMUNEX-C Immune Globulin Injection (Human), 10%, Caprylate/Chromatography Purified, Intravenous Administration: 200-600 mg/kg per intravenous infusion every 3-4 weeks

GAMUNEX-Cbiological

GAMUNEX-C Immune Globulin Injection (Human), 10%, Caprylate/Chromatography Purified, Subcutaneous Administration: weekly subcutaneous infusion at a mg/kg dose based on subject's intravenous dose and dosing interval x 1.37 conversion factor