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Safety and Efficacy of Selonsertib in Adults With Nonalcoholic Steatohepatitis (NASH) and Bridging (F3) Fibrosis

NCT03053050 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 808

Last updated 2020-06-29

Study results available
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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.

Conditions

Interventions

DRUG

SEL

Tablets administered orally once daily

DRUG

Placebo to match SEL 6 mg

Tablets administered orally once daily

DRUG

Placebo to match SEL 18 mg

Tablets administered orally once daily

Sponsors & Collaborators

Principal Investigators

  • Gilead Study Director · Gilead Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-13
Primary Completion
2019-06-19
Completion
2019-06-19
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Austria
  • Belgium
  • Brazil
  • Canada
  • France
  • Germany
  • Hong Kong
  • India
  • Israel
  • Italy
  • Japan
  • Malaysia
  • Mexico
  • Netherlands
  • New Zealand
  • Poland
  • Portugal
  • Puerto Rico
  • Singapore
  • South Korea
  • Spain
  • Switzerland
  • Taiwan
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03053050 on ClinicalTrials.gov