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

TerminadoFase 3ClinicalTrials.gov

ID: NCT03053050Tipo: INTERVENTIONALInicio: 13 de feb de 2017Fin estimado: 19 de jun de 2019

Neumología Gastroenterología Enfermedades Infecciosas

Traducción no disponible, mostrando original

Resumen

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.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 70 YearsSexo: ALL

Criterios de inclusión

Liver biopsy consistent with NASH and bridging (F3 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:
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)

Criterios de exclusión

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)

Intervenciones

drug

SEL

Tablets administered orally once daily

drug

Placebo to match SEL 6 mg

Tablets administered orally once daily

drug

Placebo to match SEL 18 mg

Tablets administered orally once daily

Ubicaciones

Hospital Italiano de Buenos Aires

Buenos Aires, Argentina

Instituto Oulton

Córdoba, Argentina

Patrocinadores

PrincipalGilead Sciences

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