drugset / Trial / NCT02881008
Myrcludex B vs Entecavir in Patients With HBeAg Negative Chronic Hepatitis B
RandomizedParallel-groupOpen-labelTreatment
Summary
A randomized, open-label multicentre clinical trial of daily Myrcludex B versus entecavir in patients with HBeAg negative chronic hepatitis B.
Timeline
- Start
- 2012-11-14
- Primary completion
- 2014-10-04
- Completion
- 2014-10-04
Publications
- Background Lavanchy D. Hepatitis B virus epidemiology, disease burden, treatment, and current and emerging prevention and control measures. J Viral Hepat. 2004 Mar;11(2):97-107. doi: 10.1046/j.1365-2893.2003.00487.x.
- Background Yan H, Zhong G, Xu G, He W, Jing Z, Gao Z, Huang Y, Qi Y, Peng B, Wang H, Fu L, Song M, Chen P, Gao W, Ren B, Sun Y, Cai T, Feng X, Sui J, Li W. Sodium taurocholate cotransporting polypeptide is a functional receptor for human hepatitis B and D virus. Elife. 2012 Nov 13;1:e00049. doi: 10.7554/eLife.00049.
- Background Trauner M, Boyer JL. Bile salt transporters: molecular characterization, function, and regulation. Physiol Rev. 2003 Apr;83(2):633-71. doi: 10.1152/physrev.00027.2002.
- Background Lok AS, McMahon BJ. Chronic hepatitis B: update 2009. Hepatology. 2009 Sep;50(3):661-2. doi: 10.1002/hep.23190. No abstract available.
- Background Nowak MA, Bonhoeffer S, Hill AM, Boehme R, Thomas HC, McDade H. Viral dynamics in hepatitis B virus infection. Proc Natl Acad Sci U S A. 1996 Apr 30;93(9):4398-402. doi: 10.1073/pnas.93.9.4398.
- Background Yan H, Zhong G, Xu G, He W, Jing Z, Gao Z, Huang Y, Qi Y, Peng B, Wang H, Fu L, Song M, Chen P, Gao W, Ren B, Sun Y, Cai T, Feng X, Sui J, Li W. Sodium taurocholate cotransporting polypeptide is a functional receptor for human hepatitis B and D virus. Elife. 2012 Nov 13;3. doi: 10.7554/eLife.00049.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Entecavir | Small molecule | 0.5 mg | Oral |
| Subject | Myrcludex B | Peptide | 0.5 mg | Subcutaneous |
| Subject | Myrcludex B | Peptide | 1 mg | Subcutaneous |
| Subject | Myrcludex B | Peptide | 2 mg | Subcutaneous |
| Subject | Myrcludex B | Peptide | 5 mg | Subcutaneous |
| Subject | Myrcludex B | Peptide | 10 mg | Subcutaneous |