Conditions: Chronic Hepatitis C Decompensated Cirrhosis Hepatitis C Virus
Keywords: Cirrhosis Hepatitis C Child-Pugh B Hepatitis C Genotype 4 Interferon-Free Hepatitis C Genotype 1 Chronic Hepatitis C Decompensated Cirrhosis Hepatitis C Virus
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 36
Healthy volunteers: no

Brief summary:
The primary objectives of this study are to assess the safety and the SVR12 rate of ombitasvir/paritaprevir/ritonavir and dasabuvir with RBV in GT1-infected participants with decompensated cirrhosis.

Detailed description:

Arms:
arm 1: ombitasvir/paritaprevir/ritonavir 25/150/100 mg once daily (QD) + dasabuvir 250 mg twice daily (BID) + ribavirin (RBV) for 12 weeks in hepatitis C virus (HCV) genotype (GT) 1b-infected participants arm 2: ombitasvir/paritaprevir/ritonavir 25/150/100 mg QD + dasabuvir 250 mg BID + RBV for 24 weeks in HCV GT1non-b (including GT1a)-infected participants arm 3: ombitasvir/paritaprevir/ritonavir 25/150/100 mg QD + RBV for 24 weeks in HCV GT4-infected participants

Interventions: intervention 1: ombitasvir/paritaprevir/ritonavir intervention 2: dasabuvir intervention 3: ribavirin
Intervention descriptions: intervention 1: tablet; paritaprevir co-formulated with ritonavir and ombitasvir intervention 2: tablet intervention 3: tablet

Protocol document: