A Study to Evaluate the Safety and Effect of ABT-450, Ritonavir and ABT-267 (ABT-450/r/ABT-267) and ABT-333 Coadministered With Ribavirin (RBV) in Hepatitis C Virus (HCV) Genotype 1-infected Adults With Compensated Cirrhosis (TURQUOISE-II)

The purpose of this study is to evaluate the safety and efficacy of ABT-450/ ritonavir/ABT-267 (ABT-450/r/ABT-267; ABT-267 also known as ombitasvir) and ABT-333 (also known as dasabuvir) coadministered with ribavirin (RBV) in hepatitis C virus (HCV) genotype 1-infected adults with compensated cirrhosis.


Study Type: Interventional
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized, Open-Label Study to Evaluate the Safety and Efficacy of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 Coadministered With Ribavirin (RBV) in Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection and Cirrhosis (TURQUOISE-II)
Enrollment: 381
Study Start Date: October 2012
Study Completion Date: September 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)

Arms:
- Experimental: ABT-450/r/ABT-267 and ABT-333, plus RBV for 12 weeks
- Experimental: ABT-450/r/ABT-267 and ABT-333, plus RBV for 24 weeks


Related journal: ABT-450/r-ombitasvir and dasabuvir with ribavirin for hepatitis C with cirrhosis.