drugset / Trial / NCT03995485
KW-136 With Sofosbuvir for Chinese Adults With Chronic Hepatitis C
Phase 3
Completed
371 enrolled
Kawin Technology Share-holding Co., Ltd.
KawinGreen Biotech Co., Ltd. · collab
NaSingle-groupOpen-labelTreatment
Summary
This study aimed to confirm efficacy and safety of KW-136, an investigational anti-hepatitis C virus (HCV) drug, combined with sofosbuvir for treatment of naive and experienced adults chronically infected with HCV. Three hundred and sixty (360) non-cirrhotic and cirrhotic subjects were medicated with KW-136 60 mg daily and sofosbuvir 400 mg daily. The treatment course lasted 12 successive weeks; thereafter all the study participants entered into a 12-week treatment-free follow-up period and an additional 12-week extension treatment-free follow-up period.
Timeline
- Start
- 2017-06-07
- Primary completion
- 2018-01-25
- Completion
- 2018-03-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | KW-136 | Unknown | 60 mg | Oral |
| Subject | Sofosbuvir | Small molecule | 400 mg | Oral |