Efficacy & Safety of Oral DS102 in Patients with Severe Acute AH
Research type
Research Study
Full title
A Randomised, Double-Blind, Placebo-Controlled, Phase II Study to Assess the Efficacy and Safety of Orally Administered DS102 in Patients with Severe Acute Decompensated Alcoholic Hepatitis
IRAS ID
256366
Contact name
Mark Thursz
Contact email
Sponsor organisation
Afimmune
Eudract number
2018-000819-25
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 11 months, 31 days
Research summary
This study will involve 2000mg DS102 per day (1000mg BD) or placebo BD for 28 days using two treatment groups consisting of approximately 60 patients each.
Patients with diagnosed severe acute decompensated alcoholic hepatitis (AH) will be enrolled in the study. The goal of the study is to compare efficacy and safety of DS102 versus placebo, when given in addition to standard of care. Based on results from previous research, it is hoped that DS102 has a beneficial effect on a number of clinical endpoints relevant for the treatment of AH, namely reduction of ALT and fibrosis. The study will be conducted at NHS hospital hepatology or gastroenterology departments. After assessment and documentation of the baseline disease characteristics by the investigator, the patient will be randomly assigned to one of the above-mentioned treatment groups. Patients will be treated according to local standard of care. In addition, patient will receive oral study medication (DS102 or placebo), according to the randomisation. During the 28 days of treatment patients will take one of the treatments twice daily within 30 minutes of a meal (morning and evening). Evaluation of efficacy and safety will be performed throughout the study. A follow-up visit will be performed on Day 90 to monitor mortality and the treatment effects in comparison to the end of treatment on Day 28.REC name
London - Brent Research Ethics Committee
REC reference
19/LO/0074
Date of REC Opinion
18 Mar 2019
REC opinion
Further Information Favourable Opinion