drugset / Trial / NCT01026610
Safety and Efficacy Study of LB80380 in the Treatment-naive Patients of Chronic Hepatitis B
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of the study is to investigate the safety and the antiviral activity of two doses of LB80380 for 48 weeks in treatment-naive patients with chronic hepatitis B infection compared to entecavir 0.5 mg.
Timeline
- Start
- 2009-08
- Primary completion
- 2010-11
- Completion
- 2011-05
Publications
- Background Fung J, Lai CL, Yuen MF. LB80380: a promising new drug for the treatment of chronic hepatitis B. Expert Opin Investig Drugs. 2008 Oct;17(10):1581-8. doi: 10.1517/13543784.17.10.1581.
- Background Yuen MF, Lee SH, Kang HM, Kim CR, Kim J, Ngai V, Lai CL. Pharmacokinetics of LB80331 and LB80317 following oral administration of LB80380, a new antiviral agent for chronic hepatitis B (CHB), in healthy adult subjects, CHB patients, and mice. Antimicrob Agents Chemother. 2009 May;53(5):1779-85. doi: 10.1128/AAC.01290-08. Epub 2009 Feb 17.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Entecavir | Small molecule | 0.5 mg | Oral |
| Subject | LB80380 | Small molecule | 90 mg | Oral |
| Subject | LB80380 | Small molecule | 150 mg | Oral |