CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 395 enrolled
Drug / intervention
SEL +5 moredrug
Likely dose
SEL 18 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03449446
NCT03449446Phase 2Completed

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Selonsertib, GS-0976, GS-9674, and Combinations in Subjects With Bridging (F3) Fibrosis or Compensated Cirrhosis (F4) Due to Nonalcoholic Steatohepatitis (NASH)

Gilead Sciences·interventional·Posted Feb 28, 2018·Updated Dec 3, 2020

In Brief

A Phase 2 clinical trial evaluating SEL, FIR, and 4 other interventions for Nonalcoholic Steatohepatitis. Completed, enrolled 395 participants across 101 sites in 6 countries.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustralia, Canada, Hong Kong, New Zealand, Puerto Rico, United States
Collaborators--

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedFeb 28, 2018
Enrollment StartMar 21, 2018
Primary CompletionOct 30, 2019
Study CompletionNov 19, 2019
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 8.3 years ago

Interventions

SELdrug

18 mg tablet administered orally once daily without regard to food

FIRdrug

20 mg tablet administered orally once daily without regard to food

CILOdrug

30 mg tablet administered orally once daily without regard to food

Placebo to match FIRdrug

Tablet administered orally once daily without regard to food

Placebo to match CILOdrug

Tablet administered orally once daily without regard to food

Placebo to match SELdrug

Tablet administered orally once daily without regard to food