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NCT03449446 · ClinicalTrials.gov registry record · Phase 2
Study to Evaluate the Safety and Efficacy of Selonsertib, Firsocostat, Cilofexor, and Combinations in Participants With Bridging Fibrosis or Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis (NASH)
A Phase 2 study, sponsored by Gilead Sciences.
- Completed
- Registry status
- Phase 2
- Development phase
- 395
- Enrollment target
NCT03449446: Completed Phase 2 study, sponsored by Gilead Sciences.
NCT03449446 is a Phase 2 study that has completed, run by Gilead Sciences. The registered enrollment target is 395 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (197% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03449446, a Phase 2 study, has completed, sponsored by Gilead Sciences.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 395 participants
- Enrollment target
Study Summary
The primary objectives of this study are: * To assess the safety and tolerability of selonsertib (SEL), firsocostat (FIR) and cilofexor (CILO), administered alone or in combination, in participants with bridging fibrosis or compensated cirrhosis due to NASH * To evaluate changes in liver fibrosis, without worsening of NASH
Interventions
- DRUG SEL
- DRUG FIR
- DRUG CILO
- DRUG Placebo to match FIR
- DRUG Placebo to match CILO
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 395 participants |
| Start Date | 2018-03-21 |
| Est. Completion | 2019-11-19 |
| Phase | Phase 2 |
What the finished NCT03449446 record still lists
NCT03449446 is an interventional study that assigns participants to a tested intervention. The registered 395 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (197% higher).
The record links to 0 conditions, and to 5 interventions - of which SEL is the first listed.
NCT03449446 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03449446 about?
NCT03449446 is a clinical study titled "Study to Evaluate the Safety and Efficacy of Selonsertib, Firsocostat, Cilofexor, and Combinations in Participants With Bridging Fibrosis or Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis (NASH)". The primary objectives of this study are: * To assess the safety and tolerability of selonsertib (SEL), firsocostat (FIR) and cilofexor (CILO), administered alone or in combination, in participants with bridging fibrosis or compensated cirrhosis due to NASH * To evaluate changes in liver fibrosis, ...
What is the current status of trial NCT03449446?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 395 participants. The study started on 2018-03-21. Estimated completion is 2019-11-19.
What interventions are being tested in trial NCT03449446?
The interventions under investigation include: SEL (DRUG), FIR (DRUG), CILO (DRUG), Placebo to match FIR (DRUG), Placebo to match CILO (DRUG).
Who is sponsoring clinical trial NCT03449446?
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 NCT03449446's enrollment target sits among peer trials
395 103rd of 2000 higher than 1,898 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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