Continuing Lamivudine Versus Switching to Entecavir in Patients Who Achieved Undetectable Hepatitis B Virus DNA

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2010-11-30

Brief Summary

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This is a randomized, open-labelled, prospective 96-week study comparing the antiviral efficacy and safety of switching to entecavir 0.5mg QD from lamivudine versus maintaining lamivudine 100mg QD treatment in CHB patients currently receiving lamivudine monotherapy.

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Detailed Description

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Entecavir has a higher potent antiviral efficacy and a lower drug resistance rate than those of Lamivudine in nucleoside-naïve CHB patients. The switch from Lamivudine to Entecavir in patients who have undetectable hepatitis B virus DNA (HBV DNA \< 60 IU/mL) may lead to more prolonged viral suppression to undetectable level by PCR method, compared to patients with continuous lamivudine treatment. The results of this study will provide a rationale for switch treatment from one antiviral to another one, especially from LAM to ETV.

Conditions

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Hepatitis B, Chronic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

entecavir 0.5 mg QD

Group Type EXPERIMENTAL

Entecavir

Intervention Type DRUG

entecavir 0.5 mg QD

B

lamivudine 100 mg QD

Group Type ACTIVE_COMPARATOR

Lamivudine

Intervention Type DRUG

lamivudine 100 mg QD

Interventions

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Entecavir

entecavir 0.5 mg QD

Intervention Type DRUG

Lamivudine

lamivudine 100 mg QD

Intervention Type DRUG

Other Intervention Names

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Baraclude 0.5mg Zeffix 100mg QD

Eligibility Criteria

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Inclusion Criteria

* Adult subjects (18-70 years of age) currently taking lamivudine monotherapy for chronic HBV infection for at least 6 months with \< HBV DNA 60 IU/mL level and HBeAg positive status.

Exclusion Criteria

* Subjects treated with other antiviral drugs (e.g. adefovir) in combination with lamivudine are not eligible for this study.
* Subjects should have ALT \< 10 x ULN, and no evidence of hepatocellular carcinoma.
* Subjects should be without serological evidence of co-infection with HCV, HIV, or HDV.
* Subjects with decompensated liver disease, as well as pregnant or breast-feeding women, will not be eligible for the study.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No