A Study to Evaluate Chronic Hepatitis C Infection in Treatment Experienced Adults

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.


Study Type: Interventional
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of ABT450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 Co-administered With Ribavirin (RBV) in Treatment-Experienced Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection (SAPPHIRE-II)
Enrollment: 395
Study Start Date: November 2012
Study Completion Date: October 2014
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)

Arms:
- Experimental: ABT-450/r/ABT-267 and ABT-333, plus RBV
- Experimental: Placebo Followed by ABT-450/r/ABT-267 and ABT-333, plus RBV