An Open-label Study to Evaluate the Efficacy and Safety of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) Co-administered With Ribavirin (RBV) for 12 or 16 Weeks in Treatment-Naïve and Treatment-Experienced Japanese Adults With Genotype 2 Chronic Hepatitis C Virus (HCV) Infection With and Without Compensated Cirrhosis (GIFT-II)

Study to Evaluate the Efficacy and Safety of ABT-450/Ritonavir/ABT- 267 (ABT-450/r/ABT-267) in Japanese Adults With Genotype 2 Chronic Hepatitis C Virus (HCV) Infection

Sponsors

Lead sponsor: AbbVie

Source AbbVie
Brief Summary

This is a Phase 3, randomized, open-label, multicenter study, enrolling non-cirrhotic and cirrhotic subjects. The purpose of this study is to evaluate the efficacy and safety of ABT-450/r/ABT-267 co-administered with weight-based RBV for 12 or 16 weeks in adult chronic HCV genotype 2-infected treatment-naïve and interferon (IFN) treatment-experienced subjects with and without compensated cirrhosis.

Overall Status Completed
Start Date January 2014
Completion Date September 2015
Primary Completion Date April 2015
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Percentage of Non-cirrhotic, Treatment-naive Participants in Each Treatment Group With a Sustained Virologic Response 12 Weeks Post-treatment (SVR12) 12 weeks after last dose of study drug
Secondary Outcome
Measure Time Frame
Percentage of Participants in Each Treatment Arm With On-treatment Virologic Failure During the Treatment Period 12 or 16 weeks (end of treatment period)
Percentage of Participants With Post-treatment Relapse within 12 weeks after the last dose of study drug
Percentage of Participants With SVR12 Weeks Post-treatment for Each Treatment Arm Within Different Subpopulations 12 weeks after last dose of study drug
Percentage of Participants in Each Treatment Arm With On-treatment Virologic Failure During the Treatment Period for Each Treatment Arm Within Different Subpopulations 12 or 16 weeks (end of treatment period)
Percentage of Participants With Post-treatment Relapse Within Different Subpopulations within 12 weeks after the last dose of study drug
Enrollment 171
Condition
Intervention

Intervention type: Drug

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

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

Intervention type: Drug

Intervention name: Ribavirin

Description: Capsule

Eligibility

Criteria:

Inclusion Criteria:

- Chronic HCV-infection prior to study enrollment

- Screening laboratory result indicating HCV genotype 2 infection

- Subject has plasma HCV ribonucleic acid (RNA) level greater than 10,000 IU/mL at Screening

- Voluntarily sign an informed consent

Exclusion Criteria:

- Co-infection of Hepatitis B Virus (HBV), human immunodeficiency virus (HIV) and any HCV genotype other than genotype 2

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

- Any cause of liver disease other than chronic HCV-infection, including but not limited to the following: hemochromatosis; alpha-1 antitrypsin deficiency; Wilson's disease; autoimmune hepatitis; alcoholic liver disease; drug-related liver disease

- Clinically significant laboratory abnormalities

- Uncontrolled clinically significant disease, disorder or medical illness

Gender: All

Minimum age: 18 Years

Maximum age: 75 Years

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Yasunori Yachi Study Director AbbVie GK
Verification Date

September 2016

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 plus RBV for 12 weeks

Arm group type: Experimental

Description: ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based ribavirin (RBV; 400 to 1,000 mg/day, divided twice daily) for 12 weeks

Arm group label: ABT-450/r/ABT-267 plus RBV for 16 weeks

Arm group type: Experimental

Description: ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based RBV (400 to 1,000 mg/day, divided twice daily) for 16 weeks

Acronym GIFT-II
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov