drugset / Trial / NCT02560649
An Exploratory Study of RGT Strategy on Optimal NUC-experienced Patients
RandomizedOpen-labelTreatment
Summary
The aim of current study is to investigate whether the HBsAg clearance rate can be improved if applying RGT((Response-Guided Therapy) strategy in HBeAg positive CHB(chronic hepatitis B) patients treated by nucleoside analogue(NUC) achieved HBVDNA\<1000copies/ml,and HBsAg\<5000IU/ml; \&HBeAg\<100PEIU/ml (or470s/co), combined with PEG-IFN a-2a for 24 weeks.
Timeline
- Start
- 2015-05
- Primary completion
- 2016-08
- Completion
- 2017-02
Publications
- Background Ning Q, Han M, Sun Y, Jiang J, Tan D, Hou J, Tang H, Sheng J, Zhao M. Switching from entecavir to PegIFN alfa-2a in patients with HBeAg-positive chronic hepatitis B: a randomised open-label trial (OSST trial). J Hepatol. 2014 Oct;61(4):777-84. doi: 10.1016/j.jhep.2014.05.044. Epub 2014 Jun 7.
- Background P. Hu et al. 2015 EASL abstract O116. PREDICTIVE VALUE OF BASELINE AND ON-TREATMENT qHBsAg LEVEL IN HBeAg POSITIVE CHB PATIENTS WHO SWITCHED FROM NUCS TO PEGYLATED INTERFERON A-2A: A FURTHER ANALYSIS FROM NEW SWITCH STUDY
- Background Brouwer WP, Xie Q, Sonneveld MJ, Zhang N, Zhang Q, Tabak F, Streinu-Cercel A, Wang JY, Idilman R, Reesink HW, Diculescu M, Simon K, Voiculescu M, Akdogan M, Mazur W, Reijnders JG, Verhey E, Hansen BE, Janssen HL; ARES Study Group. Adding pegylated interferon to entecavir for hepatitis B e antigen-positive chronic hepatitis B: A multicenter randomized trial (ARES study). Hepatology. 2015 May;61(5):1512-22. doi: 10.1002/hep.27586. Epub 2015 Feb 27.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Adefovir | Unknown | 10 mg | — |
| Subject | Entecavir | Small molecule | 0.5 mg | — |
| Subject | Lamivudine | Other / unclassified | 0.1 g | — |
| Subject | Peginterferon alfa-2a | Protein / enzyme biologic | 180 ug | — |
| Comparator | Tenofovir disoproxil fumarate | Small molecule | 300 mg | — |