NCT01704755

A Study to Evaluate the Safety and Efficacy of ABT-450/Ritonavir/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

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)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 381 (actual)
• Sponsor: AbbVie (prior sponsor, Abbott) · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety and efficacy of ABT-450/ritonavir/ABT-267 (ABT-450/r/ABT-267; ABT-450 also known as paritaprevir; 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.

Detailed description

During the treatment period of the study, participants received treatment with ABT-450/ritonavir/ABT-267 and ABT-333 coadministered with RBV for either 12 or 24 weeks. Upon completing the treatment period or premature discontinuation of the treatment period, participants entered a 48-week post-treatment period.

Conditions

• Chronic Hepatitis C Infection
• Compensated Cirrhosis

Interventions

Type	Name	Description
DRUG	ABT-450/r/ABT-267, ABT-333	Tablet; ABT-450 coformulated with ritonavir and ABT-267; ABT-333 tablet
DRUG	Ribavirin (RBV)	Capsule

Timeline

• Start date: 2012-10-01
• Primary completion: 2014-01-01
• Completion: 2014-09-01
• First posted: 2012-10-11
• Last updated: 2021-07-12
• Results posted: 2015-01-06