Phase 3
Completed N=171
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
Source: ClinicalTrials.gov NCT02023112 ↗Enrolled (actual)
171
Serious AEs
1.8%
Results posted
May 2016
Primary outcomePrimary: Percentage of Non-cirrhotic, Treatment-naive Participants in Each Treatment Group With a Sustained Virologic Response 12 Weeks Post-treatment (SVR12) — 75.0; 91.5 percentage of participants
◆ Published Evidence
Emerging
15citations · ~2 / year
Randomized Phase 3 Trial of Ombitasvir/Paritaprevir/Ritonavir and Ribavirin for Hepatitis C Virus Genotype 2-Infected Japanese Patients.
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.
Linked Publications
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Randomized Phase 3 Trial of Ombitasvir/Paritaprevir/Ritonavir and Ribavirin for Hepatitis C Virus Genotype 2-Infected Japanese Patients.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Non-cirrhotic, Treatment-naive Participants in Each Treatment Group With a Sustained Virologic Response 12 Weeks Post-treatment (SVR12) |
75.0; 91.5 | — |
| SECONDARY Percentage of Participants in Each Treatment Arm With On-treatment Virologic Failure During the Treatment Period |
8.3; 8.5; 8.3; 8.5; 0; 0 | — |
| SECONDARY Percentage of Participants With Post-treatment Relapse |
12.2; 0 | — |
| SECONDARY Percentage of Participants With SVR12 Weeks Post-treatment for Each Treatment Arm Within Different Subpopulations |
72.9; 81.4; 72.5; 85.0; 68.8; 75.8 | — |
| SECONDARY Percentage of Participants in Each Treatment Arm With On-treatment Virologic Failure During the Treatment Period for Each Treatment Arm Within Different Subpopulations |
15.3; 16.3; 15.3; 15.1; 4.7; 4.7 | — |
| SECONDARY Percentage of Participants With Post-treatment Relapse Within Different Subpopulations |
10.1; 0; 10.8; 0; 8.3; 0 | — |
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
Data sourced from ClinicalTrials.gov (NCT02023112) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.