At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 49 enrolled
Drug / intervention
IGIV-Cbiological
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, Prospective, Open-label, Non-controlled Clinical Trial to Assess the Efficacy and Safety of Immune Globulin (Human), 10% Caprylate/Chromatography Purified (IGIV-C) in Patients With Myasthenia Gravis Exacerbations
In Brief
A Phase 3 clinical trial evaluating IGIV-C for Myasthenia Gravis Exacerbations. Completed, enrolled 49 participants across 31 sites in 12 countries.
Detailed Summary
This was a multicenter, prospective, open-label, non-controlled study to assess the efficacy and safety of an IV dose of 2 g/kg of IGIV-C in subjects with MG exacerbations.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMyasthenia Gravis Exacerbations
CountriesArgentina, Belgium, Canada, Czechia, Estonia, France, Hungary, Latvia, Poland, Romania, Russia, South Africa
Collaborators--
Timeline
Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
Enrollment StartMar 2015
First PostedApr 2015
Primary CompletionApr 2018
TodayJul 2026
First PostedApr 10, 2015
Enrollment StartMar 1, 2015
Primary CompletionApr 1, 2018
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 11.2 years ago
Interventions
IGIV-Cbiological
An IV dose of 2 g/kg of IGIV-C was administered over 2 consecutive days at a dose of 1 g/kg per day.