At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 62 enrolled
Drug / intervention
IGIV-C +1 moredrug
Likely dose
Not stated in 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 Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Immune Globulin (Human), 10% Caprylate/Chromatography Purified (IGIV-C) in Symptomatic Subjects With Generalized Myasthenia Gravis
In Brief
A Phase 2 clinical trial evaluating IGIV-C and Placebo for Myasthenia Gravis, Generalized. Completed, enrolled 62 participants across 40 sites in 10 countries.
Detailed Summary
The primary objective is to evaluate whether IGIV-C improves MG symptoms as compared to placebo in subjects with MG.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMyasthenia Gravis, Generalized
CountriesBelgium, Canada, Czechia, Estonia, France, Germany, Hungary, Lithuania, Poland, United States
Collaborators--
Timeline
Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedJun 2015
Enrollment StartAug 2015
Primary CompletionJan 2018
TodayJul 2026
First PostedJun 17, 2015
Enrollment StartAug 1, 2015
Primary CompletionJan 1, 2018
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 11.0 years ago
Interventions
IGIV-Cdrug
IGIV-C: Immune Globulin Injection (Human), 10%, Caprylate/Chromatography Purified
Placebodrug