Gilead, NASH

Gilead, NASH

Title: Safety and Efficacy of Selonsertib in Adults With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis (NASH) (STELLAR-4)

Associated condition: NASH

Status: Currently enrolling

Brief summary: A double-blind, randomized, placebo-controlled Phase 3 study. The subjects were assigned to one of three treatment arms for the Randomized Phase of the study: SEL 6 mg plus placebo to match SEL 18 mg for up to 240 weeks; SEL 18 mg plus placebo to match SEL 6 mg for up to 240 weeks. During the Open-Label Phase, subjects that experienced a hepatic event prior to completing the 240-week study receive OL SEL 18 mg daily for a total treatment duration of 240 weeks.

Primary objectives: To determine if selonsertib (SEL; GS-4997) could cause fibrosis regression and reduce associated complications in adults with cirrhosis resulting from nonalcoholic steatohepatitis (NASH).

Estimated length of study: Researchers terminated the study early due to the lack of efficacy, based on analysis at Week 48, as specified in the clinical study’s established protocol.

For more detailed information on this research trial, including eligibility and study design, please visit the clinical trial page at U.S. National Library of Medicine’s website. Note you can submit your information for consideration by submitting the contact form on this page.

Submit Your Information for Consideration

HIPAA COMPLIANT FORM

Title: Safety and Efficacy of Selonsertib in Adults With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis (NASH) (STELLAR-4)

Associated condition: NASH

Status: Currently enrolling

Brief summary: A double-blind, randomized, placebo-controlled Phase 3 study. The subjects were assigned to one of three treatment arms for the Randomized Phase of the study: SEL 6 mg plus placebo to match SEL 18 mg for up to 240 weeks; SEL 18 mg plus placebo to match SEL 6 mg for up to 240 weeks. During the Open-Label Phase, subjects that experienced a hepatic event prior to completing the 240-week study receive OL SEL 18 mg daily for a total treatment duration of 240 weeks.

Primary objectives: To determine if selonsertib (SEL; GS-4997) could cause fibrosis regression and reduce associated complications in adults with cirrhosis resulting from nonalcoholic steatohepatitis (NASH).

Estimated length of study: Researchers terminated the study early due to the lack of efficacy, based on analysis at Week 48, as specified in the clinical study’s established protocol.

For more detailed information on this research trial, including eligibility and study design, please visit the clinical trial page at U.S. National Library of Medicine’s website. Note you can submit your information for consideration by submitting the contact form on this page.

Submit Your Information for Consideration