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Safety and Efficacy of Selonsertib in Adults With Nonalcoholic Steatohepatitis (NASH) and Bridging (F3) Fibrosis (STELLAR 3)

This study is currently recruiting participants.
Verified December 2017 by Gilead Sciences
Sponsor:
ClinicalTrials.gov Identifier:
NCT03053050
First Posted: February 14, 2017
Last Update Posted: December 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Gilead Sciences
  Purpose
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.

Condition Intervention Phase
Nonalcoholic Steatohepatitis Drug: SEL Drug: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Selonsertib in Subjects With Nonalcoholic Steatohepatitis (NASH) and Bridging (F3) Fibrosis

Resource links provided by NLM:


Further study details as provided by Gilead Sciences:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Proportion of Participants Who have Progression to Cirrhosis by Week 48 [ Time Frame: Week 48 ]
  • 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 Without Worsening of Fibrosis at Week 48 [ Time Frame: Week 48 ]
  • Proportion of Participants Who Have NASH Resolution Without Worsening of Fibrosis at Week 240 [ Time Frame: Week 240 ]

Estimated Enrollment: 800
Actual Study Start Date: February 13, 2017
Estimated Study Completion Date: October 2023
Estimated Primary Completion Date: January 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SEL 6 mg
SEL 6 mg plus placebo for up to 240 weeks
Drug: SEL
Tablets administered orally once daily
Other Names:
  • selonsertib
  • GS-4997
Drug: Placebo
Tablets administered orally once daily
Experimental: SEL 18 mg
SEL 18 mg plus placebo for up to 240 weeks
Drug: SEL
Tablets administered orally once daily
Other Names:
  • selonsertib
  • GS-4997
Drug: Placebo
Tablets administered orally once daily
Placebo Comparator: Placebo
Placebo for up to 240 weeks
Drug: Placebo
Tablets administered orally once daily

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Liver biopsy consistent with NASH and bridging (F3 fibrosis) according to the NASH CRN classification in the opinion of the central reader
  • Has the following laboratory parameters at the screening visit:

    • 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
    • Hemoglobin A1c (HbA1c) ≤ 9.5% (or serum fructosamine ≤ 381 μmol if HbA1c is unable to be resulted)
    • Total bilirubin ≤ 1.3 x ULN (unless an alternate etiology such as Gilbert's syndrome or hemolytic anemia is present)

Key Exclusion Criteria:

  • Prior history of decompensated liver disease including clinical ascites, hepatic encephalopathy (HE), or variceal bleeding
  • Child-Pugh (CP) score > 6, 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.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03053050


Contacts
Contact: Gilead Study Team 1-833-GILEAD-0(1-833-445-3230) STELLARteam@gilead.com

  Show 387 Study Locations
Sponsors and Collaborators
Gilead Sciences
Investigators
Study Director: Gilead Study Director Gilead Sciences
  More Information

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT03053050     History of Changes
Other Study ID Numbers: GS-US-384-1943
2016-004374-18 ( EudraCT Number )
First Submitted: February 10, 2017
First Posted: February 14, 2017
Last Update Posted: December 6, 2017
Last Verified: December 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Fatty Liver
Non-alcoholic Fatty Liver Disease
Liver Diseases
Digestive System Diseases