Clinical trial NCT02023112: 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: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hepatitis C Virus
Keywords: Japanese
Hepatitis C
Treatment naive
Treatment experienced
Genotype 2
Ombitasvir
Paritaprevir
Ritonavir
Ribavirin
VIEKIRAX Combination Tablets
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2013-12-30
Enrollment: 171
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Percentage of Non-cirrhotic, Treatment-naive Participants in Each Treatment Group With a Sustained Virologic Response 12 Weeks Post-treatment (SVR12)
timeFrame: 12 weeks after last dose of study drug
Secondary outcomes:
measure: Percentage of Participants in Each Treatment Arm With On-treatment Virologic Failure During the Treatment Period
timeFrame: 12 or 16 weeks (end of treatment period)
measure: Percentage of Participants With Post-treatment Relapse
timeFrame: within 12 weeks after the last dose of study drug
measure: Percentage of Participants With SVR12 Weeks Post-treatment for Each Treatment Arm Within Different Subpopulations
timeFrame: 12 weeks after last dose of study drug
measure: Percentage of Participants in Each Treatment Arm With On-treatment Virologic Failure During the Treatment Period for Each Treatment Arm Within Different Subpopulations
timeFrame: 12 or 16 weeks (end of treatment period)
measure: Percentage of Participants With Post-treatment Relapse Within Different Subpopulations
timeFrame: within 12 weeks after the last dose of study drug
Other outcomes:
Locations:
Study officials:
affiliation: AbbVie
name: Yasunori Yachi
role: STUDY_DIRECTOR
References:
citation: 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.