Phase 2 Study of GS-4997 with Prednisolone vs Prednisolone alone in AH
Research type
Research Study
Full title
A Phase 2, Double-Blind, Randomized Study Evaluating the\nSafety, Tolerability, and Efficacy of GS-4997 in Combination with\nPrednisolone versus Prednisolone Alone in Subjects with Severe\nAlcoholic Hepatitis (AH)
IRAS ID
213918
Contact name
Mark Thursz
Contact email
Sponsor organisation
Gilead Sciences, Inc.
Eudract number
2016-000821-37
Clinicaltrials.gov Identifier
129570, IND number
Duration of Study in the UK
1 years, 1 months, 0 days
Research summary
Alcoholic Hepatitis (AH) is an inflammatory condition of the liver caused by consuming too much alcohol over an extended period of time. When alcohol gets processed in the liver, it produces toxic chemicals which can injure the liver cells. This injury results in inflammation and leads to AH. Corticosteroids, like prednisolone are the current standard of care for helping reduce the inflammatory process. However, the limited benefits, combined with the often high rates of infection in participants with AH, make it clear that safer and more effective therapies are needed. GS-4997 has been shown to block chemical pathways in the liver that lead to inflammation of the liver cells. Its mechanism of action is complimentary to prednisolone.\nIn this study approximately 120 participants will be enrolled at multiple sites across the world to see if GS-4997 in combination with prednisolone is safer and more effective in treating AH than prednisolone alone.\nParticipants will be randomly assigned to one of the following treatment groups:\n-Treatment Group A: GS-4997 18 mg once daily + prednisolone 40 mg once daily\n-Treatment Group B: GS-4997 placebo once daily + prednisolone 40 mg once daily\nTo assess the safety and effectiveness of GS-4997 eligible participants will attend a screening period that can last up to 14 days, a treatment period of 4 weeks, and a follow-up period of 20 weeks after their last dose of study medication. The treatment period is a total of 26 weeks. There will be an option to enrol in a PK-sub study to measure changes in the amount of study medication in participants’ blood over the course of one day.\n
REC name
London - Bloomsbury Research Ethics Committee
REC reference
16/LO/1891
Date of REC Opinion
6 Jan 2017
REC opinion
Further Information Favourable Opinion