A Study to Evaluate Chronic Hepatitis C Infection in Adults With Genotype 1b Infection (PEARL-III)

The purpose of this study is to evaluate the safety and antiviral activity of ABT-450/ritonavir/ABT-267 (ABT-450/r/ABT-267; ABT-267 also known as ombitasvir) and ABT-333 (also known as dasabuvir) with and without ribavirin (RBV) in patients with chronic hepatitis C virus genotype 1b (HCV GT1b) infection without cirrhosis.


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, Controlled Study to Evaluate the Efficacy and Safety of the Combination of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 With and Without Ribavirin (RBV) in Treatment-Naïve Adults With Genotype 1b Chronic Hepatitis C Virus (HCV) Infection (PEARL-III)
Enrollment: 419
Study Start Date: December 2012
Study Completion Date: August 2014
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)

Arms:
- Experimental: ABT-450/r/ABT-267 and ABT-333, Plus RBV
- Experimental: ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV