CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 23 enrolled
Drug / intervention
HIZENTRA ®drug
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.

Search/NCT02100969
NCT02100969Phase 2Completed

Open Label Study of Subcutaneous Immunoglobulin (SCIg) in Myasthenia Gravis

Mazen Dimachkie, MD·interventional·Posted Apr 1, 2014·Updated Jun 2, 2021

In Brief

A Phase 2 clinical trial evaluating HIZENTRA ® for Myasthenia Gravis. Completed, enrolled 23 participants across 5 sites in 2 countries.

Detailed Summary

The purpose of this study is to determine whether Hizentra is a safe and effective treatment for people with myasthenia gravis (MG).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada, United States
CollaboratorsCSL Behring

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedApr 1, 2014
Enrollment StartMay 1, 2015
Primary CompletionNov 1, 2017
Study CompletionJan 1, 2018
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 12.3 years ago

Interventions

HIZENTRA ®drug

Patients must fulfill inclusion criteria and remain stable at week 0, which means QMG does not increase by 3 points, will enter receive Hizentra for 12 weeks.