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Continuing Lamivudine vs Switching to Entecavir in Patients With Detectable HBV DNA

NCT00625560 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2012-05-08

No results posted yet for this study

Summary

This is a randomized, open-labelled, prospective 96-week study comparing the antiviral efficacy and safety of switching to entecavir 1 mg QD from lamivudine versus maintaining lamivudine 100 mg QD treatment in HBV-infected subjects currently receiving lamivudine monotherapy.

Conditions

  • Hepatitis B, Chronic

Interventions

DRUG

Entecavir

entecavir 1.0 mg QD

DRUG

Lamivudine

lamivudine 100 mg QD

Sponsors & Collaborators

  • Pusan National University Hospital

    collaborator OTHER

  • Yonsei University

    lead OTHER

Principal Investigators

  • Sang Hoon Ahn, M.D.Ph.D · Yonsei Univsersity College of Medicine

  • Do Young Kim, M.D. · Yonsei University

  • Jun Yong Park, M.D · Yonsei University

  • Jeong Heo, M.D.Ph.D · Pusan National University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2008-02-29
Primary Completion
2009-11-30
Completion
2010-11-30

Countries

  • South Korea

Study Locations

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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 NCT00625560 on ClinicalTrials.gov