BRACE
Research type
Research Study
Full title
A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Proof-of-Concept, Phase 2a Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Intravenous TAK-242 in Subjects With Acute Alcoholic Hepatitis Causing Decompensation of Alcohol-related Cirrhosis and Acute-on-Chronic Liver Failure
IRAS ID
270298
Contact name
Stephen Ryder
Contact email
Sponsor organisation
Akaza Bioscience Limited
Eudract number
2019-001969-33
Clinicaltrials.gov Identifier
NA, NA
Duration of Study in the UK
1 years, 11 months, 21 days
Research summary
Acute-on-chronic liver failure (ACLF) is a life-threatening condition in people with liver disease. During ACLF, there is an “overreaction” of the body’s immune system that causes the liver and other organs in the body to suddenly stop working. The investigational medication in this study, called TAK-242, is designed to stop the overreaction, thus preventing organ failure and resulting in faster recovery for the patient. The objective of this trial is to learn whether TAK-242 works and how safe it is in patients with alcohol related liver disease who develop ACLF.
The study will take place at several hospitals in the UK, Hungary, France and Germany. A total of 60-100 patients (aged 18-75) with alcohol related liver disease who have been hospitalised as a result of ACLF will be enrolled in the study. Patients will undergo a 1-2 day screening period during which they will be asked to give consent to take part and assessed on whether they are eligible to participate.
Each patient will then be randomly (by chance) assigned to receive either TAK-242 or placebo. Neither the participant nor the doctor will know which medication the patient is receiving. The patient will receive the medication via an IV drip for 7 days, while remaining hospitalised. They will also receive usual standard-of-care treatment for ACLF.
The patients will attend 3 follow-up visits, at weeks 4, 8, 12, during which their progress will be assessed after day 8 of treatment. Patient participation will terminate after the final visit.
Several tests/assessments will be performed at screening, treatment and at the follow-up visits to determine patient safety and whether the medication is working. These may include, but are not limited to, questionnaires, physical examinations and blood or urine samples for analysis in a laboratory.REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
20/WM/0087
Date of REC Opinion
28 May 2020
REC opinion
Further Information Favourable Opinion