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

Hepatitis C Virus Clinical Trial

— GIFT-II  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02023112
• Other study ID #: M14-153
• Status: Completed
• Phase: Phase 3
• Start date: January 2014
• Est. completion date: September 2015

Study information

• Verified date: July 2021
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 171
• Est. completion date: September 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C Virus
• Hepatitis C, Chronic

Intervention

Drug:
• ABT-450/r/ABT-267
Tablet; ABT-450 coformulated with ritonavir and ABT-267
• Ribavirin
Capsule

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Percentage of Participants in Each Treatment Arm With On-treatment Virologic Failure During the 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).	12 or 16 weeks (end of treatment period)
Secondary	Percentage of Participants With Post-treatment Relapse	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.	within 12 weeks after the last dose of study drug
Secondary	Percentage of Participants With SVR12 Weeks Post-treatment for Each Treatment Arm Within Different Subpopulations	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.	12 weeks after last dose of study drug
Secondary	Percentage of Participants in Each Treatment Arm With On-treatment Virologic Failure During the Treatment Period for Each Treatment Arm Within Different Subpopulations	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).	12 or 16 weeks (end of treatment period)
Secondary	Percentage of Participants With Post-treatment Relapse Within Different Subpopulations	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.	within 12 weeks after the last dose of study drug