NCT02473952

A Study to Evaluate the Efficacy and Safety of IGIV-C in Symptomatic Subjects With Generalized Myasthenia Gravis

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 62 (actual)
• Sponsor: Grifols Therapeutics LLC · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The primary objective is to evaluate whether IGIV-C improves MG symptoms as compared to placebo in subjects with MG.

Detailed description

The primary objective is to evaluate the efficacy of IGIV-C in subjects with generalized myasthenia gravis (MG) on standard of care treatment at study entry in terms of improvement in MG symptoms as measured by the mean change in Quantitative Myasthenia Gravis (QMG) score from Baseline (Week 0) to Week 24 as compared to placebo. The safety objective of this study is to evaluate the safety and tolerability of IGIV-C loading dose of 2 g/kg followed by 7 maintenance dosages of 1 g/kg every 3 weeks through Week 21 in subjects with MG.

Conditions

• Myasthenia Gravis, Generalized

Interventions

Type	Name	Description
DRUG	IGIV-C	IGIV-C: Immune Globulin Injection (Human), 10%, Caprylate/Chromatography Purified
DRUG	Placebo

Timeline

• Start date: 2015-08-01
• Primary completion: 2018-01-01
• Completion: 2018-01-01
• First posted: 2015-06-17
• Last updated: 2019-03-05
• Results posted: 2019-03-05

Locations

40 sites across 10 countries: United States, Belgium, Canada, Czechia, Estonia, France, Germany, Hungary, Lithuania, Poland