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Safety and Efficacy Study of LB80380 in the Treatment-naive Patients of Chronic Hepatitis B

2014-08-27 03:17:31 | BioPortfolio

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.

Description

LB80380, an oral prodrug, is a promising candidate nucleotide analogue with antiviral activity against wild-type HBV. LB80380 is undergoing clinical development by LG Life Sciences for use in the treatment of chronic HBV infection.

In this study, the treatment period is 48-week with 24-week of follow-up period.

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Chronic Hepatitis B

Intervention

LB80380 90 mg, LB80380 150 mg, entecavir 0.5 mg

Location

Queen Mary Hospital
Hong Kong
Hong Kong
China

Status

Recruiting

Source

LG Life Sciences

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:17:31-0400

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Medical and Biotech [MESH] Definitions

INFLAMMATION of the LIVER in humans that is caused by HEPATITIS C VIRUS lasting six months or more. Chronic hepatitis C can lead to LIVER CIRRHOSIS.

INFLAMMATION of the LIVER with ongoing hepatocellular injury for 6 months or more, characterized by NECROSIS of HEPATOCYTES and inflammatory cell (LEUKOCYTES) infiltration. Chronic hepatitis can be caused by viruses, medications, autoimmune diseases, and other unknown factors.

INFLAMMATION of the LIVER in humans caused by HEPATITIS DELTA VIRUS in conjunction with HEPATITIS B VIRUS and lasting six months or more.

A closely related group of antigens found in the plasma only during the infective phase of hepatitis B or in virulent chronic hepatitis B, probably indicating active virus replication; there are three subtypes which may exist in a complex with immunoglobulins G.

A defective virus, containing particles of RNA nucleoprotein in virion-like form, present in patients with acute hepatitis B and chronic hepatitis. It requires the presence of a hepadnavirus for full replication. This is the lone species in the genus Deltavirus.

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