At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 60 enrolled
Drug / intervention
IGIV-C +1 moredrug
Likely dose
IGIV-C 2 gfrom 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.
A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of lGIV-C as a Corticosteroid Sparing Agent in Corticosteroid Dependent Patients With Generalized Myasthenia Gravis
In Brief
A Phase 2 clinical trial evaluating IGIV-C and Placebo for Myasthenia Gravis. Completed, enrolled 60 participants across 39 sites in 10 countries.
Detailed Summary
This is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of Immune Globulin (Human), 10% Caprylate/Chromatography Purified (IGIV-C) as a corticosteroid (CS)-sparing agent in subjects with CS-dependent Myasthenia Gravis (MG).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMyasthenia Gravis
CountriesBelgium, Canada, Czechia, Estonia, France, Germany, Hungary, Lithuania, Poland, United States
Collaborators--
Timeline
Phase 2CompletedFinished
20162017201820192020202120222023202420252026
Enrollment StartJun 2015
First PostedJun 2015
Primary CompletionFeb 2019
TodayJul 2026
First PostedJun 17, 2015
Enrollment StartJun 1, 2015
Primary CompletionFeb 1, 2019
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 11.0 years ago
Interventions
IGIV-Cdrug
Run-Phase: 1 loading dose of 2 g/kg IGIV-C and 2 maintenance doses of 1 g/kg IGIV-C Corticosteroid Tapering/IGIV-C Maintenance Phase: 1 g/kg IGIV-C every 3 weeks for up to 36 weeks
Placebodrug