A study evaluating safety and efficacy of Itacitinib in combination with corticosteroids for the treatment of first-line acute graft versus-host disease in children : An Open-Label, Single-Arm, Phase 1/2 Study Evaluating the Safety and Efficacy of Itacitinib in Combination With Corticosteroids for the Treatment of Steroid-Naive Acute Graft-Versus-Host Disease in Pediatric Subjects

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: Male or female, 28 days to less than 18 years of age, who have received an allogeneic hematopoietic stem cell transplant (allo-HSCT) and have developed Grade II to IV acute GVHD MedDRA version: 20.1Level: PTClassification code 10066260Term: Acute graft versus host diseaseSystem Organ Class: 10021428 - Immune system disorders MedDRA version: 20.1Level: PTClassification code 10066262Term: Acute graft versus host disease in skinSystem Organ Class: 10021428 - Immune system disorders MedDRA version: 20.1Level: PTClassification code 10066264Term: Acute graft versus host disease in intestineSystem Organ Class: 10021428 - Immune system disorders MedDRA version: 20.1Level: PTClassification code 10066263Term: Acute graft versus host disease in liverSystem Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Phase: Phase 1
Recruitment Status: Not yet recruiting
Study Type: Interventional

Anmerkungen:

WHO International Clinical Trials Registry Platform (https://www.who.int/ictrp/en/), First posted: 11-04-2019, Last updated: 2023-06-29

ICTRP ID:

EUCTR2018-002253-30-ES
INCB39110-120
2018-002253-30-GB

Förderinstitution / Projekttitel:

PPN (Katalog-ID):

CTG006479057