Open-Label Hepatic Impairment Study
Completed · Phase 1
Conditions studied: Hepatitis C
In brief
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.
Key facts
- Study ID
- NCT01497327
- Run by
- Gilead Sciences
- People needed
- 24
- Starts
- 2011-07-01
- Expected to finish
- 2012-01-01
- Last updated by the study team
- 2012-06-08
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Study site — San Antonio, Texas, United States
- Study site — San Juan, Puerto Rico, Puerto Rico
Full record on ClinicalTrials.gov
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