INT-787 in Subjects with Severe Alcohol-Associated Hepatitis
Research type
Research Study
Full title
A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Dose-escalation, Proof-of-Concept Study Evaluating the Safety, Tolerability, Efficacy and Pharmacokinetics of INT-787 in Subjects with Severe Alcohol-Associated Hepatitis
IRAS ID
1006726
Contact name
Thomas Capozza
Contact email
Sponsor organisation
Intercept Pharmaceuticals, Inc.
Eudract number
2022-001639-10
Clinicaltrials.gov Identifier
Research summary
The study is to investigate how safe and effective INT 787 is in adults over 18 in delaying or preventing specific medical conditions in participants with severe alcohol associated hepatitis (sAH). sAH is inflammation of the liver and the participant may also have severe scarring of the liver. There are a planned 50 sites globally. INT-787 is a man made version of bile acid which is normally made in the liver. Bile acid is used by the body to aid digestion. At this present time there is no other approved treatment for this condition. Once participants are determined eligible and have signed and dated the Informed Consent Form and have had enough time to ask questions they will be entered into the study. There are two treatment groups A & B. 80% of participants (8 out of 10) will be assigned to group A and receive the study drug and approximately 20% (2 in 10) participants will be assigned to treatment group B and will be given a placebo (a substance that looks the same but has no active drug). These will be randomly selected by a computer program. Neither the participant or study doctor will know if the participant is on the drug or placebo. Participants will be invited to a screening visit and then 8 further visits. Participation in the study can last up to 91 days, which includes up to a 7-day screening period, a 28-day treatment period, and a 56-day follow-up period. Participants will be asked to fast for up to 8 hours before each hospital visit. During these visits the study participants will undergo assessments which include physical examinations, blood and urine and stool sample analysis and ECG and blood samples taken at specific timepoints to understand how the body responds to the study drug. NHS sites will be conducting the study.
REC name
London - Chelsea Research Ethics Committee
REC reference
23/LO/0128
Date of REC Opinion
30 Aug 2023
REC opinion
Further Information Favourable Opinion