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
GIFT-II
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)
1 other identifier
interventional
171
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jan 2014
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 23, 2013
CompletedFirst Posted
Study publicly available on registry
December 30, 2013
CompletedStudy Start
First participant enrolled
January 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2015
CompletedResults Posted
Study results publicly available
May 13, 2016
CompletedJuly 30, 2021
July 1, 2021
1.2 years
December 23, 2013
April 7, 2016
July 28, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Non-cirrhotic, Treatment-naive Participants in Each Treatment Group With a Sustained Virologic Response 12 Weeks Post-treatment (SVR12)
The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid \[HCV RNA\] level less than the lower limit of quantitation \[\< LLOQ\]) 12 weeks after the last dose of study drug.
12 weeks after last dose of study drug
Secondary Outcomes (5)
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
Study Arms (2)
ABT-450/r/ABT-267 plus RBV for 12 weeks
EXPERIMENTALABT-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
ABT-450/r/ABT-267 plus RBV for 16 weeks
EXPERIMENTALABT-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
Interventions
Tablet; ABT-450 coformulated with ritonavir and ABT-267
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
Related Publications (1)
Sato K, Chayama K, Alves K, Toyoda H, Suzuki F, Kato K, Rodrigues L Jr, Zhang X, Setze C, Pilot-Matias T, Burroughs M, Redman R, Kumada H. Randomized Phase 3 Trial of Ombitasvir/Paritaprevir/Ritonavir and Ribavirin for Hepatitis C Virus Genotype 2-Infected Japanese Patients. Adv Ther. 2017 Jun;34(6):1449-1465. doi: 10.1007/s12325-017-0506-y. Epub 2017 May 23.
PMID: 28536999BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Global Medical Information
- Organization
- AbbVie
Study Officials
- STUDY DIRECTOR
Yasunori Yachi
AbbVie
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 23, 2013
First Posted
December 30, 2013
Study Start
January 1, 2014
Primary Completion
April 1, 2015
Study Completion
September 1, 2015
Last Updated
July 30, 2021
Results First Posted
May 13, 2016
Record last verified: 2021-07