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)

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

Sponsors

Lead sponsor: AbbVie (prior sponsor, Abbott)

Source AbbVie
Brief 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.

Overall Status Completed
Start Date October 2012
Completion Date September 2014
Primary Completion Date January 2014
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment 12 weeks after the last actual dose of study drug
Secondary Outcome
Measure Time Frame
Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment in the 24-week Arm Compared to the 12-week Arm 12 weeks after the last actual dose of study drug
Percentage of Participants in Each Arm With On-treatment Virologic Failure During the Treatment Period Baseline (Day 1), and Treatment Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24
Percentage of Participants With Virologic Relapse After Treatment within 12 weeks after the last dose of study drug
Enrollment 381
Condition
Intervention

Intervention type: Drug

Intervention name: ABT-450/r/ABT-267, ABT-333

Description: Tablet; ABT-450 coformulated with ritonavir and ABT-267; ABT-333 tablet

Other name: Viekira Pak; ABT-450 also known as paritaprevir; ABT-267 also known as ombitasvir; ABT-333 also known as dasabuvir

Intervention type: Drug

Intervention name: Ribavirin (RBV)

Description: Capsule

Eligibility

Criteria:

Inclusion Criteria:

- Females must be practicing specific forms of birth control on study treatment, or be post-menopausal for more than 2 years or surgically sterile

- Male or female between 18 and 70 years, inclusive, at time of Screening.

- Chronic HCV-infection prior to study enrollment.

- Screening laboratory result indicating HCV genotype 1-infection.

- Compensated cirrhosis defined as a Child-Pugh Score of less than or equal to 6 at Screening

- Subject has plasma HCV RNA level greater than 10,000 IU/mL at Screening.

Exclusion Criteria:

- Significant liver disease with any cause other than HCV as the primary cause

- Positive test result for Hepatitis B surface antigen (HBsAg) or anti-Human Immunodeficiency virus antibody (HIV Ab) at screening.

- Prior therapy with direct acting antiviral agents for the treatment of HCV, including telaprevir and boceprevir.

- Any current or past clinical evidence of Child-Pugh B or C Classification or clinical history of liver decompensation including ascites (noted on physical exam), variceal bleeding or hepatic encephalopathy.

- A positive screening ultrasound for hepatocellular carcinoma (HCC) confirmed with a subsequent CT Scan or MRI during the screening period.

Gender: All

Minimum age: 18 Years

Maximum age: 70 Years

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Roger Trinh, MD Study Director AbbVie
Verification Date

September 2015

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: ABT-450/r/ABT-267 and ABT-333, plus RBV for 12 weeks

Arm group type: Experimental

Description: ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if <75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 12 weeks

Arm group label: ABT-450/r/ABT-267 and ABT-333, plus RBV for 24 weeks

Arm group type: Experimental

Description: ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if <75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 24 weeks

Acronym TURQUOISE-II
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov