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A Study in Korea of Entecavir Versus Lamivudine in Adults With Chronic Hepatitis B Infection

NCT00393484 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 122

Last updated 2014-11-26

Study results available
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Summary

Entecavir, 0.5 mg daily, will have clinical efficacy (assessed as an undetectable hepatitis B DNA, \<300 copies/mL, by Roche Comprehensive Bio-Analytical System Amplicor polymerase chain reaction assay) that is comparable (noninferior) and potentially superior to lamivudine, 100 mg once daily, in adults with hepatitis B e antigen-negative chronic hepatitis B virus infection.

Conditions

Interventions

DRUG

Entecavir

Tablets, Oral, 0.5 mg, once daily (0-96 weeks) and (96-240 weeks)

DRUG

Lamivudine Placebo

Capsules, Oral, 0 mg, once daily (0-96 weeks)

DRUG

Lamivudine

Capsules, Oral, 100 mg, once daily (0-96 weeks) Tablets, Oral, 100 mg, once daily (96-240 weeks)

DRUG

Entecavir Placebo

Tablets, Oral, 0 mg, once daily (0-96 weeks)

Sponsors & Collaborators

Principal Investigators

  • Bristol-Myers Squibb · Bristol-Myers Squibb

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-02-28
Primary Completion
2009-01-31
Completion
2013-09-30

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Diseases
Companies

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 NCT00393484 on ClinicalTrials.gov