Phase 3
Completed N=363
Study to Evaluate the Efficacy and Safety of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) in Japanese Adults With Subgenotype 1b Chronic Hepatitis C Virus (HCV) Infection
Chronic Hepatitis C Infection
Source: ClinicalTrials.gov NCT02023099 ↗
Enrolled (actual)
363
Serious AEs
3.0%
Results posted
Nov 2015
Primary outcomePrimary: Percentage of Non-cirrhotic Treatment-Naïve Participants Who Are Eligible for Interferon (IFN)-Based Therapy and Who Have High Viral Load in the DB Active Treatment Group With a Sustained Virologic Response 12 Weeks Post-treatment — 94.6 percentage of participants
Summary
This is a phase 3, double-blinded, multicenter study. The study will consist of 2 substudies: Substudy 1 (SS1) will be double-blinded and enroll non-cirrhotic subjects and Substudy 2 (SS2) will be open label and enroll subjects with compensated cirrhosis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Non-cirrhotic Treatment-Naïve Participants Who Are Eligible for Interferon (IFN)-Based Therapy and Who Have High Viral Load in the DB Active Treatment Group With a Sustained Virologic Response 12 Weeks Post-treatment |
94.6 | — |
| SECONDARY Percentage of Participants in the Active Treatment Group With On-treatment Virologic Failure During Treatment |
0.5; 2.4 | — |
| SECONDARY Percentage of Participants in the Substudy 1 Arm A Active Treatment Group With On-treatment Virologic Failure During Treatment, by Subpopulation |
0; 0; 0; 0; 0; 3.8 | — |
| SECONDARY Percentage of Participants in the Active Treatment Group With Post-treatment Relapse |
2.4; 5.0 | — |
| SECONDARY Percentage of Participants in Substudy 1 Arm A Active Treatment Group With Post-treatment Relapse, by Subpopulation |
2.8; 0; 4.5; 0; 0; 4.0 | — |
| SECONDARY Percentage of Participants in the Active Treatment Group With Sustained Virologic Response 12 Weeks Post-treatment |
94.9; 90.5 | — |
| SECONDARY Percentage of Participants in Substudy 1 Arm A Active Treatment Group With Sustained Virologic Response 12 Weeks Post-Treatment, by Subpopulation |
94.2; 94.6; 100; 91.3; 96.1; 95.5 | — |
Eligibility Criteria
Inclusion Criteria
- Chronic HCV-infection prior to study enrollment
- Screening laboratory result indicating HCV subgenotype 1b infection
- Subject has plasma HCV RNA level greater than 10,000 IU/mL at Screening
- Voluntarily sign an informed consent
- Females must be practicing specific forms of birth control on study treatment, or be post-menopausal for more than 2 years or surgically sterile
Exclusion Criteria
- Co-infection of Hepatitis B Virus (HBV), human immunodeficiency virus (HIV) or any HCV genotype other than subgenotype 1b
- 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 (NCT02023099). 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.