drugset / Trial / NCT01266005
A Study to Compare and Evaluate Intrahepatic cccDNA Reduction After Administrating Clevudine or Entecavir in the Chronic HBV Patients
RandomizedParallel-groupOpen-labelTreatment
Summary
This is a open, randomized, parallel study. Subjects will have Clevudine or Entecavir therapy for 48 weeks(Clevudine:Entecavir = 2:1), and subjects who have Complete Response(HBV DNA negative and ALT normal) will have follow-up period for additional 48 weeks.
Timeline
- Start
- 2009-08
- Primary completion
- 2013-08
- Completion
- 2014-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Clevudine | Small molecule | 30 mg | — |
| Comparator | Entecavir | Small molecule | 0.5 mg | — |