A Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) in Treatment-Naïve and Treatment-Experienced Japanese Adults With Subgenotype 1b Chronic Hepatitis C Virus (HCV) Infection With and Without Compensated Cirrhosis (GIFT I)

Study to Evaluate the Efficacy and Safety of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) in Japanese Adults With Subgenotype 1b Chronic Hepatitis C Virus (HCV) Infection

Sponsors

Lead sponsor: AbbVie

Source AbbVie
Brief Summary

This is a phase 3, double-blinded, multicenter study. The study will consist of 2 substudies: Substudy 1 (SS1) will be double-blinded and enroll non-cirrhotic subjects and Substudy 2 (SS2) will be open label and enroll subjects with compensated cirrhosis.

Overall Status Completed
Start Date December 2013
Completion Date October 2015
Primary Completion Date October 2014
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Percentage of Non-cirrhotic Treatment-Naïve Participants Who Are Eligible for Interferon (IFN)-Based Therapy and Who Have High Viral Load in the DB Active Treatment Group With a Sustained Virologic Response 12 Weeks Post-treatment 12 weeks after the last dose of study drug
Secondary Outcome
Measure Time Frame
Percentage of Participants in the Active Treatment Group With On-treatment Virologic Failure During Treatment up to 12 weeks
Percentage of Participants in the Substudy 1 Arm A Active Treatment Group With On-treatment Virologic Failure During Treatment, by Subpopulation up to 12 weeks
Percentage of Participants in the Active Treatment Group With Post-treatment Relapse within 12 weeks after last dose of study drug
Percentage of Participants in Substudy 1 Arm A Active Treatment Group With Post-treatment Relapse, by Subpopulation within 12 weeks after last dose of study drug
Percentage of Participants in the Active Treatment Group With Sustained Virologic Response 12 Weeks Post-treatment 12 weeks after last dose of study drug
Percentage of Participants in Substudy 1 Arm A Active Treatment Group With Sustained Virologic Response 12 Weeks Post-Treatment, by Subpopulation 12 weeks after last dose of study drug
Enrollment 363
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: Placebo

Description: Tablet

Arm group label: Substudy 1, Arm B: DB Placebo, Followed by OL 2-DAA

Eligibility

Criteria:

Inclusion Criteria:

- Chronic HCV-infection prior to study enrollment

- Screening laboratory result indicating HCV subgenotype 1b infection

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

- Voluntarily sign an informed consent

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

Exclusion Criteria:

- Co-infection of Hepatitis B Virus (HBV), human immunodeficiency virus (HIV) or any HCV genotype other than subgenotype 1b

- 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
Nori 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 3
Arm Group

Arm group label: Substudy 1, Arm A: DB 2-DAA

Arm group type: Experimental

Description: Double-blind (DB) 150 mg ABT-450/100 mg ritonavir/25 mg ABT-267 (2 direct-acting antiviral agents [2-DAA]) once daily (QD) for 12 weeks in participants without cirrhosis

Arm group label: Substudy 1, Arm B: DB Placebo, Followed by OL 2-DAA

Arm group type: Placebo Comparator

Description: DB placebo QD for 12 weeks followed by open-label (OL) 150 mg ABT-450/100 mg ritonavir/25 mg ABT-267 (2-DAA) QD for 12 weeks in participants without cirrhosis

Arm group label: Substudy 2, Arm C: OL 2-DAA

Arm group type: Experimental

Description: OL 150 mg ABT-450/100 mg ritonavir/25 mg ABT-267 (2-DAA) QD for 12 weeks in participants with compensated cirrhosis

Acronym GIFT I
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov