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NCT02854631 · ClinicalTrials.gov registry record · Phase 2
Selonsertib in Combination With Prednisolone Versus Prednisolone Alone in Participants With Severe Alcoholic Hepatitis (AH)
A Phase 2 study of Alcoholic Hepatitis (AH), sponsored by Gilead Sciences.
- Completed
- Registry status
- Phase 2
- Development phase
- 104
- Enrollment target
- 20
- Study locations
NCT02854631: Completed Phase 2 study of Alcoholic Hepatitis (AH), sponsored by Gilead Sciences.
NCT02854631 is a Phase 2 study of Alcoholic Hepatitis (AH) that has completed, run by Gilead Sciences. The registered enrollment target is 104 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (22% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02854631, a Phase 2 study of Alcoholic Hepatitis (AH), has completed, sponsored by Gilead Sciences.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 104 participants
- Enrollment target
- 20
- Study locations
Study Summary
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).
Primary Outcome
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 dis
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Prednisolone
- DRUG Selonsertib
Study Locations (20)
Other
- Medizinische Universitat Graz - Graz
- Universitätsklinik für Innere Medizin I - Innsbruck
- Medical University Vienna - Vienna
- Cliniques Universitaires UCL Saint-Luc - Brussels
- CUB Hopital Erasme - Brussels
- Ghent University Hospital - Ghent
- Universitair Ziekenhuis Leuven - Leuven
- Centre Hospitalier Universitaire de Liege - Liège
California
- Southern California Research Centers - Coronado
- Cedars Sinai Medical Center - Los Angeles
Arkansas
- University of Arkansas for Medical Sciences - Little Rock
Florida
- Cleveland Clinic Florida - Weston
Louisiana
- Oschner Medical Center - New Orleans
Massachusetts
- Beth Israel Deaconess Medical Center - Boston
Michigan
- University of Michigan - Ann Arbor
Pennsylvania
- University of Pennsylvania - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 104 participants |
| Start Date | 2016-09-01 |
| Est. Completion | 2018-05-31 |
| Phase | Phase 2 |
What the finished NCT02854631 record still lists
NCT02854631 is an interventional study that assigns participants to a tested intervention. The registered 104 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (22% lower).
The record links to 1 condition, with Alcoholic Hepatitis (AH) appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT02854631 names 20 study sites across 12 states, led by Other, California, Arkansas.
Frequently Asked Questions
What is clinical trial NCT02854631 about?
NCT02854631 is a clinical study titled "Selonsertib in Combination With Prednisolone Versus Prednisolone Alone in Participants With Severe Alcoholic Hepatitis (AH)". 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).
What is the current status of trial NCT02854631?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 104 participants. The study started on 2016-09-01. Estimated completion is 2018-05-31.
What conditions does trial NCT02854631 study?
This clinical trial studies the following conditions: Alcoholic Hepatitis (AH).
What interventions are being tested in trial NCT02854631?
The interventions under investigation include: Placebo (DRUG), Prednisolone (DRUG), Selonsertib (DRUG).
Who is sponsoring clinical trial NCT02854631?
This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02854631 being conducted?
This trial has 20 study locations across Arkansas, California, Florida, Louisiana, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02854631's enrollment target sits among peer trials
104 660th of 2000 higher than 1,337 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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