drugset / Trial / NCT00823550
Antiviral Therapy in Hepatitis B Virus (HBV)-Related Advanced Liver Disease Patients
Phase 4
Unknown
462 enrolled
Yonsei University
Ajou University · collabBristol-Myers Squibb · collabChung-Ang University · collabHallym University Medical Center · collabHanyang University · collabInha University Hospital · collabInje University · collabKangbuk Samsung Hospital · collabKeimyung University · collabKonkuk University Hospital · collabKorea University · collabKorea University Anam Hospital · collabKyungpook National University Hospital · collabPusan National University Hospital · collabSeverance Hospital · collabSoonchunhyang University Hospital · collabThe Catholic University of Korea · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
This is a randomized, open label, phase IV, multicenter study for efficacy and safety of lamivudine versus entecarvir therapy in HBV-related advanced liver disease patients with high viral load and normal or slightly elevated transaminase.
Timeline
- Start
- 2009-01
- Primary completion
- 2014-07
- Completion
- 2015-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Entecavir | Small molecule | 0.5 mg | — |
| Comparator | Lamivudine | Other / unclassified | 100 mg | — |