Conditions: Chronic Hepatitis C Infection
Keywords: Chronic Hepatitis C Infection Early Stage Hepatocellular Carcinoma
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 3
Healthy volunteers: no

Brief summary:
The purpose of this study is to evaluate the safety and efficacy of ombitasvir/paritaprevir/ritonavir (OBV/PTV/r), with or without dasabuvir (DSV) coadministered with or without ribavirin (RBV) for 12 or 24 weeks in adult patients with genotype 1 or genotype 4 chronic HCV infection and treated early stage Hepatocellular Carcinoma with compensated cirrhosis.

Detailed description:

Arms:
arm 1: OBV/PTV/r (ombitasvir/paritaprevir/ritonavir \[25 mg/150 mg/100 mg once daily\]) with or without dasabuvir (250 mg twice daily) with or without weight-based ribavirin (± RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 or 24 weeks, dosed as per label based on HCV genotype/subtype and presence of cirrhosis.

Interventions: intervention 1: ombitasvir/paritaprevir/ritonavir and dasabuvir intervention 2: ombitasvir/paritaprevir/ritonavir intervention 3: ribavirin
Intervention descriptions: intervention 1: Tablet; ombitasvir coformulated with paritaprevir and ritonavir, dasabuvir tablet intervention 2: Tablet; ombitasvir coformulated with paritaprevir and ritonavir intervention 3: Tablet

Protocol document: