Status:
COMPLETED
Open-Label Hepatic Impairment Study
Lead Sponsor:
Gilead Sciences
Conditions:
Hepatitis C
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 functi...
Detailed Description
This study is designed per the Food and Drug Administration (FDA) guidance for patients with impaired hepatic function to assess the influence of hepatic impairment on the PK and pharmacodynamics (PD)...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT01497327
Start Date
July 1 2011
End Date
January 1 2012
Last Update
June 8 2012
Active Locations (2)
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1
San Antonio, Texas, United States
2
San Juan, Puerto Rico, Puerto Rico, 00927