Open-Label Hepatic Impairment Study

• Status: Completed
• Trial end date: 2012-01-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will be conducted in Hepatitis C positive patients to determine whether the pharmacodynamic effects of PSI-7977 or PSI-352938 are similar to HCV-infected patients with normal hepatic function, which may allow inclusion of patients with cirrhosis and varying degrees of hepatic dysfunction in future clinical studies.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gilead Sciences
• Treatments: Sofosbuvir

Criteria

Inclusion Criteria:

• Hepatic impaired Males or females of non-childbearing potential aged > 18 years with Chronic HCV-infection

• Naïve to all direct acting anti-viral (DAA) treatments for chronic HCV infection.

• Documented Cirrhosis

Exclusion Criteria:

• Prior PEG/RBV null responders.

• Unstable cardiac disease, recent Myocardial infarction, or family history of QTc prolongation or unexplained cardiac arrest.

• Positive test at Screening for anti-HAV IgM Ab, HBsAg, anti-HBc IgM Ab, or anti-human immunodeficiency virus (HIV) Ab.

• History of clinically significant medical condition associated with other chronic liver disease

• Any current signs or symptoms of severe hepatic encephalopathy

• History of gastric or esophageal variceal bleeding in which varices have not been adequately treated with medication and surgical procedures

• Prior placement of a portosystemic shunt

• History of hepatorenal, or hepatopulmonary syndrome.

• Active spontaneous bacterial peritonitis.

• Use of medications associated with QT prolongation within 28 days prior to dosing.

• Current Hypotension

• History of Torsades de Pointes, evidence of an active or suspected cancer, or a history of malignancy, Abnormal hematological and biochemical parameters