Adults 18 to 70, any sex, with Alcoholic Hepatitis (AH). Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Percentage of Participants With Treatment-Emergent (TE) Adverse Events (AE), Serious AEs (SAE), AEs Leading to Premature Study Drug Discontinuation, and Grade 3 or 4 Laboratory AbnormalitiesPrimary· Up to Day 28 plus 30 days
An AE was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An adverse event was therefore any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. An SAE is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect. Laboratory toxicity grading was based on Co
TEAEs
Group
Value
95% CI
Selonsertib + Prednisolone
94.0
Placebo + Prednisolone
94.2
TE SAEs
Group
Value
95% CI
Selonsertib + Prednisolone
50.0
Placebo + Prednisolone
40.4
TEAEs (discontinuation of Selonsertib/Placebo)
Group
Value
95% CI
Selonsertib + Prednisolone
18.0
Placebo + Prednisolone
7.7
TEAEs (discontinuation of Prednisolone)
Group
Value
95% CI
Selonsertib + Prednisolone
14.0
Placebo + Prednisolone
11.5
TEAEs (discontinuation of both drugs in regimen)
Group
Value
95% CI
Selonsertib + Prednisolone
14.0
Placebo + Prednisolone
7.7
Laboratory abnormalities (Grade 3 or 4)
Group
Value
95% CI
Selonsertib + Prednisolone
72.0
Placebo + Prednisolone
72.0
Laboratory abnormalities (Grade 3)
Group
Value
95% CI
Selonsertib + Prednisolone
42.0
Placebo + Prednisolone
52.0
Laboratory abnormalities (Grade 4)
Group
Value
95% CI
Selonsertib + Prednisolone
30.0
Placebo + Prednisolone
20.0
Percentage of Participants Who Died by Day 28Secondary· Day 28
The percentage of participants who died by Day 28 was calculated.
Group
Value
95% CI
Selonsertib + Prednisolone
4.3
Placebo + Prednisolone
4.0
Percentage of Participants Who Died by Week 8Secondary· Week 8
The percentage of participants who died by Week 8 was calculated.
Group
Value
95% CI
Selonsertib + Prednisolone
20.5
Placebo + Prednisolone
6.1
Percentage of Participants Who Died by Week 12Secondary· Week 12
The percentage of participants who died by Week 12 was calculated.
Group
Value
95% CI
Selonsertib + Prednisolone
25.6
Placebo + Prednisolone
10.2
Percentage of Participants Who Died by Week 24Secondary· Week 24
The percentage of participants who died by Week 24 was calculated.
Group
Value
95% CI
Selonsertib + Prednisolone
31.7
Placebo + Prednisolone
18.8
Percentage of Participants With Survival at Day 28 Using Kaplan-MeierSecondary· Day 28
The percentage of participants with survival at Day 28 using Kaplan-Meier was calculated.
Group
Value
95% CI
Selonsertib + Prednisolone
95.7
84.0 – 98.9
Placebo + Prednisolone
96.1
85.2 – 99.0
Percentage of Participants With Survival at Week 8 Using Kaplan-MeierSecondary· Week 8
The percentage of participants with survival at Week 8 using Kaplan-Meier was calculated.
Group
Value
95% CI
Selonsertib + Prednisolone
80.0
65.1 – 89.1
Placebo + Prednisolone
94.0
82.6 – 98.0
Percentage of Participants With Survival at Week 12 Using Kaplan-MeierSecondary· Week 12
The percentage of participants with survival at Week 12 using Kaplan-Meier was calculated.
Group
Value
95% CI
Selonsertib + Prednisolone
75.3
59.8 – 85.5
Placebo + Prednisolone
89.9
77.5 – 95.7
Percentage of Participants With Survival at Week 24 Using Kaplan-MeierSecondary· Week 24
The percentage of participants with survival at Week 24 using Kaplan-Meier was calculated.
Group
Value
95% CI
Selonsertib + Prednisolone
70.3
54.3 – 81.6
Placebo + Prednisolone
81.7
67.7 – 90.0
Percentage of Participants Who Received a Liver TransplantSecondary· Day 28, Week 8, Week 12, and Week 24
The percentage of participants who received a liver transplant by week 24 was calculated.
Day 28
Group
Value
95% CI
Selonsertib + Prednisolone
2.2
Placebo + Prednisolone
0
Week 8
Group
Value
95% CI
Selonsertib + Prednisolone
2.8
Placebo + Prednisolone
0
Week 12
Group
Value
95% CI
Selonsertib + Prednisolone
3.0
Placebo + Prednisolone
0
Week 24
Group
Value
95% CI
Selonsertib + Prednisolone
6.9
Placebo + Prednisolone
2.6
Percentage of Participants With Hepatorenal Syndrome (HRS)Secondary· Up to 24 weeks
The occurrence of HRS was confirmed based on the following diagnostic criteria from the International Ascites Club (IAC): 1) Cirrhosis with ascites, 2) Diagnosis of acute kidney injury (AKI) according to the ICA-AKI criteria, 3) Absence of shock, 4) No current or recent treatment with nephrotoxic drugs, and 5) Absence of parenchymal renal disease as indicated by proteinuria \>500 mg/day, microhematuria (\> 50 red blood cells per high power field) and/or abnormal renal ultrasonography.
Group
Value
95% CI
Selonsertib + Prednisolone
4.2
Placebo + Prednisolone
2.0
Percentage of Participants With InfectionSecondary· Up to 24 weeks
The occurrence of bacterial, fungal, or viral infections was recorded. An infection was considered definite in participants with clinical evidence of infection and a positive culture from a normally sterile source (with the exception of spontaneous bacterial peritonitis).
Group
Value
95% CI
Selonsertib + Prednisolone
37.5
Placebo + Prednisolone
29.4
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse Events: Up to Day 28 plus 30 days; All-Cause Mortality: Up to 24 weeks.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The primary objective of this study is to evaluate the safety and tolerability of selonsertib (GS-4997) in combination with prednisolone versus prednisolone alone in participants with severe alcoholic hepatitis (AH).
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT02509624 — Study to Evaluate the Pharmacokinetics of Selonsertib in Participants With Normal and Impaired Hepatic Function
· Phase 1
· completed
Other recruiting trials for Alcoholic Hepatitis (AH)
Currently open trials in the same condition.
NCT06740318 — Recompensation in Alcohol Related Hepatitis
· NA
· recruiting
Other Gilead Sciences trials
Trials by the same sponsor.
NCT07115368 — Study of GS-1219 in Participants With HIV-1
· Phase 1
· terminated
NCT06784973 — Study of Obeldesivir to Treat Children With Respiratory Syncytial Virus (RSV) Infection
· Phase 2
· terminated
NCT06683482 — A Qualitative Study on Advanced Breast Cancer Patients and Their Caregivers in Spain
· completed
NCT06613685 — Study of Oral Weekly GS-1720 and GS-4182 Compared With Biktarvy in People With HIV-1 Who Have Not Been Treated
· Phase 2, PHASE3
· terminated
NCT06585150 — Study of Obeldesivir to Treat Nonhospitalized Adults With Acute Respiratory Syncytial Virus (RSV) Infection
· Phase 2
· terminated
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Gilead Sciences
Last refreshed: 6 February 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02854631.