Conditions: Chronic Hepatitis C Infection
Keywords: Hepatitis C Treatment-Experienced Null responder Partial Responder Chronic Hepatitis Hepatitis C Genotype 1 Interferon-Free Hepatitis C Virus Relapser Non responder Viekira Pak ombitasvir ribavirin ritonavir paritaprevir dasabuvir
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 395
Healthy volunteers: no

Brief summary:
The purpose of this study is to evaluate the safety and efficacy of ABT-450, ritonavir and ABT-267 (ABT-450/r/ABT-267; ABT-267 also known as ombitasvir) and ABT-333 (also known as dasabuvir) co-administered with ribavirin (RBV) in hepatitis C virus genotype 1 infected treatment-experienced adults.

Detailed description:

Arms:
arm 1: Double-blind ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks arm 2: Double-blind placebo for 12 weeks, followed by open-label ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks

Interventions: intervention 1: ABT-450/r/ABT-267, ABT-333 intervention 2: Ribavirin intervention 3: Placebo for ABT-450/r/ABT-267 intervention 4: Placebo for ABT-333 intervention 5: Placebo for ribavirin
Intervention descriptions: intervention 1: Tablet; ABT-450 coformulated with ritonavir and ABT-267, ABT-333 tablet intervention 2: Capsule (double-blind treatment period), tablet (open-label treatment period) intervention 3: Tablet intervention 4: Tablet intervention 5: Capsule

Protocol document: