SEL
Drug18 mg tablet administered orally once daily without regard to food
NCT Number: NCT03449446
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
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Notify Me18 year–80 year
All sexes
Interventional
Phase 2
Royal Brisbane & Women's Hospital, Herston, Queensland, Australia
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol defined Inclusion/ Exclusion criteria may apply
18 mg tablet administered orally once daily without regard to food
20 mg tablet administered orally once daily without regard to food
Other names: GS-0976
30 mg tablet administered orally once daily without regard to food
Other names: GS-9674
Tablet administered orally once daily without regard to food
Tablet administered orally once daily without regard to food
Tablet administered orally once daily without regard to food
Time frame: First dose date up to 48 weeks plus 30 days
Time frame: First dose date up to 48 weeks plus 30 days
Treatment-emergent laboratory abnormalities were defined as values that increase at least one toxicity grade from baseline. Participants with any laboratory abnormality were reported.
Time frame: Week 48
Fibrosis improvement was defined as ≥ 1-stage decrease from baseline in fibrosis according to the NASH clinical research network classification (CRN) classification. Worsening of NASH was defined as ≥ 1-point increase from baseline in hepatocellular ballooning or lobular inflammation. The 95% CI was based on the Clopper-Pearson method.
Gilead Sciences
Industry
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)
Acronym: ATLAS
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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