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NCT03053050 · ClinicalTrials.gov registry record · Phase 3
Safety and Efficacy of Selonsertib in Adults With Nonalcoholic Steatohepatitis (NASH) and Bridging (F3) Fibrosis
A Phase 3 study, sponsored by Gilead Sciences.
- Terminated
- Registry status
- Phase 3
- Development phase
- 808
- Enrollment target
NCT03053050: Clinical Trial Phase 3 study, sponsored by Gilead Sciences.
NCT03053050 is a Phase 3 study that was terminated before completion, run by Gilead Sciences. The registered enrollment target is 808 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03053050, a Phase 3 study, was terminated before completion, sponsored by Gilead Sciences.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 808 participants
- Enrollment target
Study Summary
The primary objective of this study is to evaluate whether selonsertib (SEL; GS-4997) can cause fibrosis regression and reduce progression to cirrhosis and associated complications in adults with NASH and bridging (F3) fibrosis.
Primary Outcome
Fibrosis improvement was defined as ≥ 1-stage decrease from baseline in fibrosis according to the NASH CRN classification. NASH CRN fibrosis stages range from 0 to 4, with higher scores indicating greater fibrosis (0=None, 4=Cirrhosis). Worsening of NASH was defined as ≥ 1 point increase from baseline in hepatocellular ballooning or lobular inflammation according to the Non-Alcoholic Fatty Liver Disease (NAFLD) Activity Score (NAS) criteria. As defined by NAS, hepatocellular ballooning ranges fr
Interventions
- DRUG SEL
- DRUG Placebo to match SEL 6 mg
- DRUG Placebo to match SEL 18 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 808 participants |
| Start Date | 2017-02-13 |
| Est. Completion | 2019-06-19 |
| Phase | Phase 3 |
Why NCT03053050 stopped before completion
NCT03053050 is an interventional study that assigns participants to a tested intervention. The registered 808 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 3 interventions - of which SEL is the first listed.
NCT03053050 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03053050 about?
NCT03053050 is a clinical study titled "Safety and Efficacy of Selonsertib in Adults With Nonalcoholic Steatohepatitis (NASH) and Bridging (F3) Fibrosis". The primary objective of this study is to evaluate whether selonsertib (SEL; GS-4997) can cause fibrosis regression and reduce progression to cirrhosis and associated complications in adults with NASH and bridging (F3) fibrosis.
What is the current status of trial NCT03053050?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 808 participants. The study started on 2017-02-13. Estimated completion is 2019-06-19.
What interventions are being tested in trial NCT03053050?
The interventions under investigation include: SEL (DRUG), Placebo to match SEL 6 mg (DRUG), Placebo to match SEL 18 mg (DRUG).
Who is sponsoring clinical trial NCT03053050?
This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03053050's enrollment target sits among peer trials
808 410th of 2000 higher than 1,590 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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