drugset / Trial / NCT01023217
Entecavir Plus Adefovir in Lamivudine-Resistant Chronic Hepatitis B Patients Who Fail Lamivudine Plus Adefovir
RandomizedParallel-groupOpen-labelTreatment
Summary
The presence of persistent inadequate or suboptimal virologic response is a strong risk factor for viral resistance and breakthrough and also for disease progression of chronic hepatitis B, and thus, a change in therapy is required. The combination of entecavir (ETV) and adefovir (ADV) is a promising treatment for patients with lamivudine (LAM)-resistance who show suboptimal response to the combination of LAM and ADV. In this randomized, open labeled trial,the investigators will compare the efficacy of continuation of ADV plus LAM versus switch to ADV plus ETV in adults with LAM-resistant chronic hepatitis B who shows suboptimal response to the combination treatment of ADV and LAM.
Timeline
- Start
- 2009-11
- Primary completion
- 2012-07
- Completion
- 2012-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Entecavir | Small molecule | 1 mg | Oral |
| Comparator | Lamivudine | Other / unclassified | 100 mg | Oral |
| Background | Adefovir | Unknown | 10 mg | Oral |