This trial will evaluate the safety and efficacy of HepaStem compared to placebo in patients with a cirrhotic liver condition called Acute on Chronic Liver Failure (ACLF). The study will be performed in multiple centers and in a double-blinded manner, meaning neither the patients nor the treating physicians know who is on placebo or the study drug. : Randomized, placebo-controlled, double blind, multi-centre Phase IIb study to evaluate the efficacy and safety of HepaStem in patients with Acute on Chronic Liver Failure (ACLF) - DHELIVER - HEP102 - DHELIVER

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: in phase 1b part: advanced and/or treatment refractory solid malignancies in phase 2 part : advanced or metastatic HER2-negative breast cancer MedDRA version: 20.1Level: PTClassification code 10055113Term: Breast cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 21.1Level: PTClassification code 10070308Term: Refractory cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 21.0Level: LLTClassification code 10048683Term: Advanced cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps);Therapeutic area: Diseases [C] - Cancer [C04]
Phase: Phase 1
Recruitment Status: Authorised-recruitment may be ongoing or finished
Study Type: Interventional

Anmerkungen:

WHO International Clinical Trials Registry Platform (https://www.who.int/ictrp/en/), First posted: 19-12-2019, Last updated: 2023-06-29

ICTRP ID:

EUCTR2019-003051-11-DK
AA1817

Förderinstitution / Projekttitel:

PPN (Katalog-ID):

CTG005788269