Phase 3
Completed N=121
The Efficacy and Safety of ABT-493/ABT-530 in Adults With Chronic Hepatitis C Virus Genotype 4, 5, or 6 Infection (ENDURANCE-4)
Source: ClinicalTrials.gov NCT02636595 ↗Enrolled (actual)
121
Serious AEs
0.8%
Results posted
Sep 2017
Primary outcomePrimary: Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) — 99.2 percentage of participants
Summary
The purpose of this study is to evaluate the effect of response to treatment by evaluating the percentage of subjects achieving a 12-week sustained virologic response (SVR12) after 12 weeks of treatment with ABT-493/ABT-530 and to evaluate the safety of the regimen in participants with chronic hepatitis C virus (HCV) genotype (GT) 4, 5, or 6 infection.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) |
99.2 | — |
| SECONDARY Percentage of Participants With On-treatment Virologic Failure |
— | — |
| SECONDARY Percentage of Participants With Post-treatment Relapse |
— | — |
Eligibility Criteria
Inclusion Criteria
- Screening laboratory result indicating hepatitis C virus (HCV) genotype (GT) 4, 5, or 6 infection.
- Chronic HCV infection.
- HCV treatment-naïve or treatment experienced (interferon [IFN] or pegylated interferon [pegIFN] with or without ribavirin [RBV]; sofosbuvir [SOF] plus RBV with or without pegIFN).
- Non-cirrhotic participants.
Exclusion Criteria
- History of severe, life-threatening or other significant sensitivity to any excipient of the study drugs.
- Female who is pregnant, planning to become pregnant during the study, or breastfeeding; or male whose partner is pregnant or planning to become pregnant during the study.
- Recent (within 6 months prior to study drug administration) history of drug or alcohol abuse that could preclude adherence to the protocol in the opinion of the investigator.
- Positive test result at Screening for hepatitis B surface antigen (HBsAg) or anti-human immunodeficiency virus antibody (HIV Ab).
- Co-infection with more than one HCV genotype.
Data sourced from ClinicalTrials.gov (NCT02636595). 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.