A study investigating Immune Globulin (Human), 10% Caprylate/Chromatography Purified (IGIV-C) for the treatment of patients with Myasthenia Gravis, dependent on Corticosteroids. The patients will receive 2g/kg of IP as a loading dose. The loading dosage is followed by maintenance doses of 1 g/kg administered every third week until Visit 13 (Week 36). During maintenance doses the investigator will try to slowly reduce the patient's corticosteroid dose. : A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Immune Globulin (Human), 10% Caprylate/ chromatography Purified (lGIV -C) as a Corticosteroid Sparing Agent in Corticosteroid Dependent Patients with Generalized Myasthenia Gravis

Medienart:

Klinische Studie

Erscheinungsjahr:

2023

Erschienen:

2023

Enthalten in:

WHO International Clinical Trials Registry Platform - (2023) vom: 21. Juni Zur Gesamtaufnahme - year:2023

Sprache:

Englisch

Links:

Volltext [kostenfrei]

Themen:

610
Medical Condition: Myasthenia Gravis MedDRA version: 20.0Level: PTClassification code 10028417Term: Myasthenia gravisSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Phase: Phase 2
Recruitment Status: Not yet recruiting
Study Type: Interventional

Anmerkungen:

WHO International Clinical Trials Registry Platform (https://www.who.int/ictrp/en/), First posted: 25-05-2015, Last updated: 2023-06-29

ICTRP ID:

EUCTR2013-005099-17-LT
GTI1306

Förderinstitution / Projekttitel:

PPN (Katalog-ID):

CTG004644476