Sofosbuvir and Ribavirin in Patients With Chronic HCV With Cirrhosis and Portal Hypertension With or Without Liver Decompensation
| Status: | Completed |
|---|---|
| Conditions: | High Blood Pressure (Hypertension), Gastrointestinal, Hepatitis |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Gastroenterology, Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | July 2012 |
| End Date: | October 2015 |
A Phase 2, Multicenter, Open-Label, Randomized Study to Investigate the Safety and Efficacy of GS-7977 and Ribavirin Administered for 48 Weeks in Patients Infected With Chronic HCV With Cirrhosis and Portal Hypertension With or Without Liver Decompensation
This study will evaluate the antiviral efficacy of combination therapy with sofosbuvir (SOF)
plus ribavirin (RBV) for 48 weeks in adults with compensated and decompensated chronic
hepatitis C virus (HCV) infection. Approximately 50 adults will be randomized (1:1) to
receive study drug for 48 weeks or take part in an untreated observational arm for the first
24 weeks followed by study drug for another 48 weeks.
plus ribavirin (RBV) for 48 weeks in adults with compensated and decompensated chronic
hepatitis C virus (HCV) infection. Approximately 50 adults will be randomized (1:1) to
receive study drug for 48 weeks or take part in an untreated observational arm for the first
24 weeks followed by study drug for another 48 weeks.
Inclusion Criteria:
- Chronic infection with Hepatitis C with HCV RNA > 1000 IU/mL
- Individuals with cirrhosis with Child-Pugh score < 10
- esophageal or gastric varices on endoscopy within 6 months prior to or at screening
- Hepatic Venous Pressure Gradient (HVPG) > 6 mmHg
- Body mass index (BMI) ≥ 18 kg/m^2
- Naïve to all nucleotides/nucleoside treatments for chronic HCV infection
Exclusion Criteria:
- Have any serious or active medical or psychiatric illness which, in the opinion of
the investigator, would interfere with subject treatment, assessment, or compliance
- HIV or chronic hepatitis B virus (HBV) infection (HBsAg positive)
- Alpha-fetoprotein (AFP) > 50 unless negative imaging for hepatic masses within the
last 6 months or during screening
- Refractory ascites as defined by requiring paracentesis > twice within 1 month prior
to screening
- Active variceal bleeding within 6 months of screening
- Expected survival of < 1 year
- History of hepatorenal, or hepatopulmonary syndrome.
- Evidence of renal impairment (CrCl < 50 mL/min)
- History of major organ transplantation, including liver transplant.
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