Last reviewed · How we verify
A Single-Arm, Open-Label Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Adults With Chronic Hepatitis C Virus Genotype 4, 5, or 6 Infection (ENDURANCE-4)
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.
Details
| Lead sponsor | AbbVie |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 121 |
| Start date | 2015-11 |
| Completion | 2017-01 |
Conditions
- Hepatitis C Virus
Interventions
- ABT-493/ABT-530
Primary outcomes
- Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) — 12 weeks after the last actual dose of study drug
SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification \[\<LLOQ\]) 12 weeks after the last dose of study drug.