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

NCT02473952 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2019-03-05

Study results available
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Summary

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

Conditions

  • Myasthenia Gravis, Generalized

Interventions

DRUG

IGIV-C

IGIV-C: Immune Globulin Injection (Human), 10%, Caprylate/Chromatography Purified

DRUG

Placebo

Sponsors & Collaborators

  • Grifols Therapeutics LLC

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-31
Primary Completion
2018-01-31
Completion
2018-01-31

Countries

  • United States
  • Belgium
  • Canada
  • Czechia
  • Estonia
  • France
  • Germany
  • Hungary
  • Lithuania
  • Poland

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02473952 on ClinicalTrials.gov