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Lamivudine Therapy in Patients With Prior Entecavir Treatment and Undetectable Viral Load

NCT01013272 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2015-12-02

No results posted yet for this study

Summary

Patients with chronic hepatitis B and treated with entecavir for over 6 months (with no previous other antiviral treatment) will be invited to participate in this study. They will be eligible if their liver tests are normal and their viral load is undetectable. Patients will be switched to lamivudine treatment to assess whether lamivudine can maintain adequate suppression of the hepatitis B virus after successful treatment with entecavir. Patients will be monitored closely after switching treatment at 1 months and then every 3 monthly. If there is any evidence of increase in viral load then patients will be given the option of changing back to entecavir.

Conditions

  • Hepatitis B, Chronic

Interventions

DRUG

Entecavir

Entecavir 0.5mg orally daily

DRUG

Lamivudine

Lamivudine 100mg orally, daily

Sponsors & Collaborators

  • The University of Hong Kong

    lead OTHER

Principal Investigators

  • James Fung, MBChB · The University of Hong Kong

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
2007-06-30
Primary Completion
2010-07-31
Completion
2010-07-31

Countries

  • China

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 NCT01013272 on ClinicalTrials.gov