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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 is a Phase 2 study that has completed, run by Gilead Sciences. The registered enrollment target is 395 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03449446
The ClinicalTrials.gov registry entry for NCT03449446 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 395 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Gilead Sciences, which has 504 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which SEL is the first listed.
NCT03449446 reports 0 study locations.
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.
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