GS-US-384-1943-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

Investigator: Eugene Schiff

Institutional Protocol #: 20170066

National Clinical Trials Identifier: NCT03053050

Funding Agency/Sponsor: GILEAD SCIENCES INC

Division: Unknown

Therapeutic Area:

Phase: Phase III

Enrolling Sites: University of Miami Medical Group

Enrolling Since: 8/31/2017


Purpose/Abstract:


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.




Eligibility 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.


Gender: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Accepts healthy volunteers: No

Please note that this is written for scientific review, and if there are any questions or clarifications needed, please contact

Sonia Carvalho, Manager, Compliance
(305) 243 4639
scarvalho@miami.edu

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