Safety and Efficacy Study of LB80380 in the Patients With Lamivudine-Refractory Chronic Hepatitis B

Phase 1/2 Completed 65 enrolled LG Life Sciences

Non-randomizedOpen-labelTreatment

Summary

The purpose of the study is to investigate the safety and the antiviral activity of ascending multiple oral doses of LB80380 for 12 weeks in adults with lamivudine-refractory chronic hepatitis B infection.

Timeline

Start: 2004-03
Primary completion: 2006-08
Completion: 2007-12

Publications

Yuen MF, Han KH, Um SH, Yoon SK, Kim HR, Kim J, Kim CR, Lai CL. Antiviral activity and safety of LB80380 in hepatitis B e antigen-positive chronic hepatitis B patients with lamivudine-resistant disease. Hepatology. 2010 Mar;51(3):767-76. doi: 10.1002/hep.23462.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	LB80380	Small molecule	30 mg	Oral
Subject	LB80380	Small molecule	60 mg	Oral
Subject	LB80380	Small molecule	90 mg	Oral
Subject	LB80380	Small molecule	150 mg	Oral
Subject	LB80380	Small molecule	240 mg	Oral
Background	Adefovir dipivoxil	Small molecule	10 mg	—

Safety and Efficacy Study of LB80380 in the Patients With Lamivudine-Refractory Chronic Hepatitis B

Summary

Timeline

Publications

Drugs

Indications