Safety and Efficacy of Selonsertib in Adults With 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 - 70 |
Updated: | 3/7/2019 |
Start Date: | January 30, 2017 |
End Date: | April 2019 |
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)
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.
cause fibrosis regression and reduce associated complications in adults with cirrhosis due to
NASH.
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.
We found this trial at
129
sites
Virginia Commonwealth University Since our founding as a medical school in 1838, Virginia Commonwealth University...
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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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Univ of Rochester Medical Center One of the nation's top academic medical centers, the University...
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University of Utah Research is a major component in the life of the U benefiting...
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Univ of Washington Founded in 1861 by a private gift of 10 acres in what...
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Cleveland Clinic Florida Cleveland Clinic Florida, located in Weston, West Palm Beach, Palm Beach Gardens...
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Mercy Medical Center "Mercy Medical Center" is a hospital located in Baltimore, Maryland. The landmark...
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8901 Rockville Pike
Bethesda, Maryland 20889
Bethesda, Maryland 20889
(301) 295-4000
Walter Reed National Military Medical Center The Walter Reed National Military Medical Center is one...
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Chapel Hill, North Carolina 27599
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1000 Blythe Boulevard
Charlotte, North Carolina 28204
Charlotte, North Carolina 28204
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Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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University of Chicago Medical Center The University of Chicago Medicine has been at the forefront...
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675 North Saint Clair Street
Chicago, Illinois 60611
Chicago, Illinois 60611
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University of Cincinnati The University of Cincinnati offers students a balance of educational excellence and...
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890 West Faris Road
Greenville, South Carolina 29605
Greenville, South Carolina 29605
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Houston Methodist Hospital Houston Methodist is comprised of a leading academic medical center in the...
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16511 Northcross Drive
Huntersville, North Carolina 28078
Huntersville, North Carolina 28078
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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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La Jolla, California 92093
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Los Angeles, California 90073
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Memphis, Tennessee 38104
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1430 Tulane Ave Suite SL32
New Orleans, Louisiana 70112
New Orleans, Louisiana 70112
(504) 588-5912
Tulane University Health Sciences Center One of the nation's most recognized centers for medical education,...
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Icahn School of Medicine at Mount Sinai Icahn School of Medicine at Mount Sinai is...
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5801 Bremo Road
Newport News, Virginia 23226
Newport News, Virginia 23226
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734 Fairmount Avenue
Pasadena, California 91105
Pasadena, California 91105
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Thomas Jefferson University Hospital Our hospitals in Center City Philadelphia share a 13-acre campus with...
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Philadelphia, Pennsylvania 19104
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St. Joseph's Hospital and Medical Center St. Joseph's is a nationally recognized center for quality...
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