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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)

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ClinicalTrials.gov Identifier: NCT02023112
Recruitment Status : Completed
First Posted : December 30, 2013
Results First Posted : May 13, 2016
Last Update Posted : October 24, 2016
Sponsor:
Information provided by (Responsible Party):
AbbVie

Tracking Information
First Submitted Date  ICMJE December 23, 2013
First Posted Date  ICMJE December 30, 2013
Results First Submitted Date  ICMJE April 7, 2016
Results First Posted Date  ICMJE May 13, 2016
Last Update Posted Date October 24, 2016
Study Start Date  ICMJE January 2014
Actual Primary Completion Date April 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 7, 2016)
Percentage of Non-cirrhotic, Treatment-naive Participants in Each Treatment Group With a Sustained Virologic Response 12 Weeks Post-treatment (SVR12) [ Time Frame: 12 weeks after last dose of study drug ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: December 23, 2013)
Percentage of non-cirrhotic, treatment-naive subjects in each treatment group with a sustained virologic response 12 weeks post-treatment [ Time Frame: 12 weeks after last dose of study drug ]
Hepatitis C Virus ribonucleic acid less than the lower limit of quantification
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 13, 2016)
  • Percentage of Participants in Each Treatment Arm With On-treatment Virologic Failure During the Treatment Period [ Time Frame: 12 or 16 weeks (end of treatment period) ]
    On-treatment virologic failure was defined as rebound (confirmed HCV RNA ≥ LLOQ after HCV RNA < LLOQ during treatment, or confirmed increase from nadir in HCV RNA [> 1 log10 IU/mL above nadir] at any time point during treatment) or failure to suppress HCV during treatment (all on-treatment values of HCV RNA ≥ LLOQ with at least 6 weeks of treatment).
  • Percentage of Participants With Post-treatment Relapse [ Time Frame: within 12 weeks after the last dose of study drug ]
    Relapse by post-treatment Week 12 was defined as confirmed HCV RNA ≥ LLOQ between end of treatment and 12 weeks after last actual dose of study drug for a participant with HCV RNA < LLOQ at the final treatment visit and who completed study treatment. Completion of treatment was defined as a study drug duration ≥ 77 days for the 12-week treatment arm or ≥ 105 days for the 16-week treatment arm.
  • Percentage of Participants With SVR12 Weeks Post-treatment for Each Treatment Arm Within Different Subpopulations [ Time Frame: 12 weeks after last dose of study drug ]
    The percentage of participants with SVR12 in each treatment arm within the following subpopulations: noncirrhotic participants; noncirrhotic treatment-experienced (T-exp) participants; noncirrhotic participants who relapsed after prior IFN-based therapy (relapsers); noncirrhotic T-exp participants who were non-responders to prior IFN-based therapy; noncirrhotic T-exp participants who were intolerant to IFN-based therapy; participants with compensated cirrhosis.
  • Percentage of Participants in Each Treatment Arm With On-treatment Virologic Failure During the Treatment Period for Each Treatment Arm Within Different Subpopulations [ Time Frame: 12 or 16 weeks (end of treatment period) ]
    The percentage of participants with on-treatment virologic failure in each treatment arm within the following subpopulations: noncirrhotic participants; noncirrhotic treatment-experienced (T-exp) participants; participants with compensated cirrhosis. On-treatment virologic failure was defined as rebound (confirmed HCV RNA ≥ LLOQ after HCV RNA < LLOQ during treatment, or confirmed increase from nadir in HCV RNA [> 1 log10 IU/mL above nadir] at any time point during treatment) or failure to suppress HCV during treatment (all on-treatment values of HCV RNA ≥ LLOQ with at least 6 weeks of treatment).
  • Percentage of Participants With Post-treatment Relapse Within Different Subpopulations [ Time Frame: within 12 weeks after the last dose of study drug ]
    The percentage of participants with relapse by post-treatment Week 12 in each treatment arm within the following subpopulations: noncirrhotic participants; noncirrhotic treatment-experienced (T-exp) participants; participants with compensated cirrhosis. Relapse by post-treatment Week 12 was defined as confirmed HCV RNA ≥ LLOQ between end of treatment and 12 weeks after last actual dose of study drug for a participant with HCV RNA < LLOQ at the final treatment visit and who completed study treatment. Completion of treatment was defined as a study drug duration ≥ 77 days for the 12-week treatment arm or ≥ 105 days for the 16-week treatment arm.
Original Secondary Outcome Measures  ICMJE
 (submitted: December 23, 2013)
  • The percentage of subjects in each treatment arm with on-treatment virologic failure during the treatment period [ Time Frame: up to 12 or 16 weeks ]
    Percentage of subjects with confirmed quantifiable Hepatitis C virus ribonucleic acid among subjects with previous unquantifiable Hepatitis C virus ribonucleic acid during treatment,with confirmed increase from nadir in Hepatitis C virus ribonucleic acid during treatment, or with persistently quantifiable Hepatitis C virus ribonucleic acid during treatment with at least 6 weeks of treatment
  • The percentage of subjects in each arm with post-treatment relapse [ Time Frame: within 12 weeks after the last dose of study drug ]
    The percentage of subjects with confirmed quantifiable Hepatitis C virus ribonucleic acid among subjects with unquantifiable Hepatitis C virus ribonucleic acid at the end of treatment
  • The percentage of subjects with sustained virologic response 12 weeks post-treatment for each treatment arm within different subpopulations [ Time Frame: 12 weeks after last dose of study drug ]
    Hepatitis C virus ribonucleic acid less than the lower limit of quantification
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hepatitis C Virus
Intervention  ICMJE
  • Drug: ABT-450/r/ABT-267
    Tablet; ABT-450 coformulated with ritonavir and ABT-267
    Other Names:
    • ABT-267 also known as ombitasvir
    • ABT-450 also known as paritaprevir
    • ritonavir also known as Norvir
    • VIEKIRAX Combination Tablets
    • VIEKIRA Combination Tablets
    • Technivie
    • Qurevo
  • Drug: Ribavirin
    Capsule
Study Arms  ICMJE
  • Experimental: ABT-450/r/ABT-267 plus RBV for 12 weeks
    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
    Interventions:
    • Drug: ABT-450/r/ABT-267
    • Drug: Ribavirin
  • Experimental: ABT-450/r/ABT-267 plus RBV for 16 weeks
    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
    Interventions:
    • Drug: ABT-450/r/ABT-267
    • Drug: Ribavirin
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 10, 2015)
171
Original Estimated Enrollment  ICMJE
 (submitted: December 23, 2013)
150
Actual Study Completion Date  ICMJE September 2015
Actual Primary Completion Date April 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries Japan
 
Administrative Information
NCT Number  ICMJE NCT02023112
Other Study ID Numbers  ICMJE M14-153
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party AbbVie
Study Sponsor  ICMJE AbbVie
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Yasunori Yachi AbbVie GK
PRS Account AbbVie
Verification Date September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP