Safety and Efficacy of Selonsertib, GS-0976, GS-9674, and Combinations in Participants With Bridging Fibrosis or Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis (NASH)
Status: | Active, not recruiting |
---|---|
Conditions: | Gastrointestinal, Hepatitis |
Therapuetic Areas: | Gastroenterology, Immunology / Infectious Diseases |
Healthy: | No |
Age Range: | 18 - 80 |
Updated: | 4/6/2019 |
Start Date: | March 21, 2018 |
End Date: | October 2019 |
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)
The primary objectives of this study are:
- To assess the safety and tolerability of selonsertib (SEL), GS-0976, and GS-9674,
administered alone or in combination, in participants with bridging fibrosis or
compensated cirrhosis due to Nonalcoholic Steatohepatitis (NASH)
- To evaluate changes in liver fibrosis, without worsening of NASH
- To assess the safety and tolerability of selonsertib (SEL), GS-0976, and GS-9674,
administered alone or in combination, in participants with bridging fibrosis or
compensated cirrhosis due to Nonalcoholic Steatohepatitis (NASH)
- To evaluate changes in liver fibrosis, without worsening of NASH
Key Inclusion Criteria:
- Liver biopsy consistent with NASH and bridging fibrosis (F3) and cirrhosis (F4) in the
opinion of the central reader
- In participants who have never had a liver biopsy, liver stiffness by FibroScan® and
Enhanced Liver Fibrosis (ELF™) Test score at Screening
- Screening laboratory parameters, as determined by the central laboratory:
- Estimated glomerular filtration rate (eGFR) ≥ 60 mL/min, as calculated by the
Cockcroft-Gault equation
- HbA1c ≤ 9.5%
- Alanine aminotransferase (ALT) < 5 x Upper Limits of Normal (ULN)
- Platelet count ≥ 125,000/μL
Key Exclusion Criteria:
- Prior history of decompensated liver disease including ascites, hepatic
encephalopathy, or variceal bleeding
- Child-Pugh (CP) score > 6 at Screening, unless due to an alternative etiology such as
Gilbert's syndrome or therapeutic anticoagulation
- Model for End-Stage Liver Disease (MELD) score > 12 at Screening, unless due to an
alternate etiology such as therapeutic anticoagulation
- Other causes of liver disease based on medical history and/or centralized review of
liver histology, including but not limited to: alcoholic liver disease, hepatitis B,
hepatitis C, autoimmune disorders (eg, primary biliary cholangitis, primary sclerosing
cholangitis, autoimmune hepatitis), drug-induced hepatotoxicity, Wilson disease,
clinically significant iron overload, or alpha-1-antitrypsin deficiency requiring
treatment
- History of liver transplantation
- Current or prior history of hepatocellular carcinoma
Note: Other protocol defined Inclusion/ Exclusion criteria may apply
We found this trial at
82
sites
Houston Methodist Hospital Houston Methodist is comprised of a leading academic medical center in the...
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Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
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Piedmont Hospital For more than a century, Piedmont Healthcare has been a recognized leader in...
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Mercy Medical Center "Mercy Medical Center" is a hospital located in Baltimore, Maryland. The landmark...
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303 E Chicago Ave
Chicago, Illinois 60611
Chicago, Illinois 60611
(312) 503-8194
Northwestern University Feinberg School of Medicine Northwestern University Feinberg School of Medicine, founded in 1859,...
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Dallas, Texas 75390
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Falls Church, Virginia 22042
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University of Kansas Medical Center The University of Kansas Medical Center serves Kansas through excellence...
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Saint Luke's Hospital, Kansas City Saint Luke's Hospital is a not-for-profit tertiary referral center committed...
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Icahn School of Medicine at Mount Sinai Icahn School of Medicine at Mount Sinai is...
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Philadelphia, Pennsylvania 19104
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Thomas Jefferson University We are dedicated to the health sciences and committed to educating professionals,...
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3459 Fifth Avenue
Pittsburgh, Pennsylvania 15213
Pittsburgh, Pennsylvania 15213
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Richmond, Virginia 23226
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Virginia Mason Medical Center Established in 1920, Virginia Mason began as an 80-bed hospital with...
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