A-TANGO Phase 2 Study
Research type
Research Study
Full title
Phase2, double-blind, randomized, placebo-controlled, multicentre study to evaluation the safety, efficacy, and pharmacokinetics of TAK-242 and Granulocyte Colony-Stimulating Factor (G-CSF) (G-TAK) in subjects with severe alcoholic hepatitis (sAH) and acute-on-chronic liver failure (ACLF).
IRAS ID
1005490
Contact name
Daniel Green
Contact email
Sponsor organisation
Yaqrit Ltd
Eudract number
2022-000128-39
ISRCTN Number
ISRCTN36798599
Research summary
This clinical research study is a medical study that helps answer important questions about how safe the investigational medications are and whether and how well they work. The investigational medication, TAK-242, is aimed at stopping an “over-reaction” of the immune system (the body’s defence system) whilst G-CSF encourages the liver cells to grow. In patients with severe alcoholic hepatitis (sAH) and acute-on-chronic liver failure (ACLF), this over-reaction may cause the liver and other organs in the body to suddenly stop working (organ failure). It is hoped that by blocking this over-reaction and encouraging patients' liver cells to grow and their condition may improve.
The purpose of the study is to learn more about whether the investigational medications, (TAK-242 and G-CSF) work and how safe they are compared with a placebo in people with severe alcohol-related liver disease.
The patients who will be enrolled in the study will receive the investigational medication and/or placebo in combination on top of the standard of care.
The length of participation in the study will depend on patients' condition. If condition worsens they may have to leave the study. The maximum duration of study participation is 90 days (about 3 months). There are up to 3 study visits, including a stay at the study centre for at least 13 days during the screening and treatment periods. Eligible patients who participate in the study wil undergo a number of different procedures and asessments including Physical examination, ECG, EEG, Blood and urine tests, completion of questionnaires and a liver biopsy.
The study will run in a number of countries includint the UK where patients can be treated in the participating NHS sites.REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
22/EM/0087
Date of REC Opinion
22 May 2022
REC opinion
Further Information Favourable Opinion