drugset / Trial / NCT00962533
EFFicacy Optimization Research of Telbivudine Therapy
Phase 4
Completed
606 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 trial is to prove that the strategy of treatment adjustment at W24 according to virological response based on ROADMAP concept is better than standard of care strategy.
Timeline
- Start
- 2009-08
- Primary completion
- 2012-04
- Completion
- 2012-08
Publications
- Background Keeffe EB, Zeuzem S, Koff RS, Dieterich DT, Esteban-Mur R, Gane EJ, Jacobson IM, Lim SG, Naoumov N, Marcellin P, Piratvisuth T, Zoulim F. Report of an international workshop: Roadmap for management of patients receiving oral therapy for chronic hepatitis B. Clin Gastroenterol Hepatol. 2007 Aug;5(8):890-7. doi: 10.1016/j.cgh.2007.05.004. Epub 2007 Jul 13.
- Huang Q, Zhou B, Cai D, Zong Y, Wu Y, Liu S, Mercier A, Guo H, Hou J, Colonno R, Sun J. Rapid Turnover of Hepatitis B Virus Covalently Closed Circular DNA Indicated by Monitoring Emergence and Reversion of Signature-Mutation in Treated Chronic Hepatitis B Patients. Hepatology. 2021 Jan;73(1):41-52. doi: 10.1002/hep.31240. Epub 2020 Dec 1.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Telbivudine | Small molecule | 600 mg | Oral |