drugset / Trial / NCT01529255
EFFORT Extension Study
Phase 4
Unknown
576 enrolled
Nanfang Hospital, Southern Medical University
Major Science and Technology Special Project of China Eleventh Five-year · collabNovartis · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
* The purpose of this study is to to prove that the long-term efficacy of strategy of treatment adjustment at W24 according to virological response based on ROADMAP concept is better than standard of care strategy. * To evaluate the off-treatment durability of HBeAg seroconversion in patients who discontinued treatment due to sustained HBeAg seroconversion and HBV DNA\<300copies/ml with over 12 months consolidation treatment
Timeline
- Start
- 2011-08
- Primary completion
- 2015-08
- Completion
- 2015-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Telbivudine | Small molecule | 600 mg | Oral |
| Comparator | Adefovir | Unknown | 10 mg | Oral |