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

NCT01026610 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 115

Last updated 2012-10-05

No results posted yet for this study

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.

Conditions

Interventions

DRUG

LB80380 90 mg

LB80380 90 mg + placebo tablets, once daily, for 48 weeks

DRUG

LB80380 150 mg

LB80380 60 mg + 90 mg tablets, once daily, for 48 weeks

DRUG

entecavir 0.5 mg

entecavir 0.5 mg tablet, once daily, for 48 weeks

Sponsors & Collaborators

  • LG Life Sciences

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-08-31
Primary Completion
2010-11-30
Completion
2011-05-31

Countries

  • China
  • South Korea

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01026610 on ClinicalTrials.gov