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

NCT01242787 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 115

Last updated 2012-04-16

No results posted yet for this study

Summary

The purpose of the study is to investigate the long-term safety and the antiviral activity of the optimal doses of LB80380 for additional 48 weeks in treatment-naive patients with chronic hepatitis B infection compared to entecavir 0.5 mg.

Conditions

Interventions

DRUG

LB80380

Optimal dose of LB80380, by oral for 48 weeks (optimal dose will be chosen early 2011 based on the results of LG-BVCL007 study)

DRUG

Entecavir 0.5 mg

Entecavir 0.5 mg, by oral 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
66 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-08-31
Primary Completion
2012-09-30
Completion
2012-09-30

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 NCT01242787 on ClinicalTrials.gov