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

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ClinicalTrials.gov Identifier: NCT03053063
Recruitment Status : Completed
First Posted : February 14, 2017
Last Update Posted : May 9, 2019
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Tracking Information
First Submitted Date  ICMJE February 10, 2017
First Posted Date  ICMJE February 14, 2017
Last Update Posted Date May 9, 2019
Actual Study Start Date  ICMJE January 30, 2017
Actual Primary Completion Date April 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 10, 2017)
  • Proportion of Participants Who Achieve a ≥ 1-Stage Improvement in Fibrosis According to the NASH Clinical Research Network (CRN) Classification Without Worsening of NASH [ Time Frame: Week 48 ]
  • Event-Free Survival (EFS) at Week 240 as Assessed by Time to the First Clinical Event [ Time Frame: Week 240 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03053063 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 10, 2017)
  • Proportion of Participants Who have a ≥ 1-Stage Improvement in Fibrosis Without Worsening of NASH at Week 240 [ Time Frame: Week 240 ]
  • Proportion of Participants Who Have a ≥ 1-Stage Improvement in Fibrosis at Week 48 [ Time Frame: Week 48 ]
  • Proportion of Participants Who Have a ≥ 1-Stage Improvement in Fibrosis at Week 240 [ Time Frame: Week 240 ]
  • Proportion of Participants Who Have NASH Resolution at Week 48 [ Time Frame: Week 48 ]
  • Proportion of Participants Who Have NASH Resolution at Week 240 [ Time Frame: Week 240 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of Selonsertib in Adults With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis (NASH)
Official Title  ICMJE A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Selonsertib in Subjects With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis (NASH)
Brief Summary The primary objective of this study is to evaluate whether selonsertib (SEL; GS-4997) can cause fibrosis regression and reduce associated complications in adults with cirrhosis due to NASH.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Condition  ICMJE Nonalcoholic Steatohepatitis
Intervention  ICMJE
  • Drug: SEL
    Tablets administered orally once daily
    Other Names:
    • selonsertib
    • GS-4997
  • Drug: Placebo
    Tablets administered orally once daily
Study Arms  ICMJE
  • Experimental: SEL 6 mg
    SEL 6 mg plus placebo for up to 240 weeks
    Interventions:
    • Drug: SEL
    • Drug: Placebo
  • Experimental: SEL 18 mg
    SEL 18 mg plus placebo for up to 240 weeks
    Interventions:
    • Drug: SEL
    • Drug: Placebo
  • Placebo Comparator: Placebo
    Placebo for up to 240 weeks
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 23, 2018)
883
Original Estimated Enrollment  ICMJE
 (submitted: February 10, 2017)
800
Actual Study Completion Date  ICMJE April 30, 2019
Actual Primary Completion Date April 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Key Inclusion Criteria:

  • Liver biopsy consistent with NASH and cirrhosis (F4 fibrosis) according to the NASH Clinical Research Network (CRN) classification, in the opinion of the central reader
  • Has the following laboratory parameters at the screening visit, as determined by the central laboratory:

    • Alanine aminotransferase (ALT) ≤ 8 x upper limit of normal (ULN)
    • Creatinine Clearance (CLcr) ≥ 30 milliliter/minute (mL/min), as calculated by the Cockcroft-Gault equation
    • HbA1c ≤ 9.5% (or serum fructosamine ≤ 381 μmol if HbA1c is unable to be resulted)

Key Exclusion Criteria:

  • Prior history of decompensated liver disease including clinical ascites, hepatic encephalopathy (HE), or variceal bleeding
  • Child-Pugh (CP) score > 7, as determined at screening, unless due to therapeutic anti-coagulation
  • Model for End-stage Liver Disease (MELD) score > 12, as determined at screening, unless due to therapeutic anti-coagulation
  • Other causes of liver disease including, but not limited to, alcoholic liver disease, hepatitis B, hepatitis C, autoimmune disorders, drug-induced hepatotoxicity, Wilson disease, iron overload, and alpha-1-antitryspin deficiency, based on medical history and/or centralized review of liver histology.
  • History of liver transplantation
  • Current or history of hepatocellular carcinoma (HCC)

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Austria,   Belgium,   Canada,   France,   Germany,   Hong Kong,   India,   Israel,   Italy,   Japan,   Korea, Republic of,   Mexico,   New Zealand,   Poland,   Puerto Rico,   Singapore,   Spain,   Switzerland,   Taiwan,   United Kingdom,   United States
Removed Location Countries Netherlands
 
Administrative Information
NCT Number  ICMJE NCT03053063
Other Study ID Numbers  ICMJE GS-US-384-1944
2016-004148-13 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Gilead Sciences
Study Sponsor  ICMJE Gilead Sciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Gilead Study Director Gilead Sciences
PRS Account Gilead Sciences
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP