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Trial ID: NCT01852604
A Randomized Study to Evaluate the Safety and Efficacy of IDX719 in Combinations With Simeprevir and/or TMC647055/Ritonavir With or Without Ribavirin for 12 Weeks in Subjects With Chronic Hepatitis C Infection
Professor of Medicine (Gastroenterology and Hepatology) and, by courtesy, of Epidemiology and Population Health
- Must have Genotype 1a, 1b, 4 or 6 HCV infection.
- Documented clinical history compatible with chronic hepatitis C
- HCV treatment-naïve or interferon/RBV-treatment relapsed (Part C)
- Must agree to use an acceptable double method of birth control (one of which must be a
barrier method) for at least 6 months after the last dose of study drugs.
- Female participants who are pregnant or breastfeeding.
- Body Mass Index (BMI) > 36 kg/m2.
- Co-infected with hepatitis B virus or human immunodeficiency virus (HIV).
- History of hepatocellular carcinoma (HCC) or findings suggestive of possible HCC.
- History or signs of decompensated liver disease: ascites, variceal bleeding, hepatic
encephalopathy, spontaneous bacterial peritonitis, or other clinical signs of portal
hypertension or hepatic insufficiency.
- Has one or more known primary or secondary causes of liver disease, other than
- History of, or active, acute or chronic, liver or biliary injury due to drugs, toxins,
non-HCV viral hepatitis, gallstones or other etiologies
- Donated blood or had significant blood loss 30 days prior to dosing
drug: Ribavirin (RBV)
drug: Ritonavir (RTV)
biological: Pegylated interferon (Peg-IFN)
other: Samatasvir matching placebo
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