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

NCT ID: NCT01013272

Last Updated: 2015-12-02

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

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-30

Study Completion Date

2010-07-31

Brief Summary

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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.

Detailed Description

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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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Entecavir

Ongoing entecavir 0.5mg daily

Group Type ACTIVE_COMPARATOR

Entecavir

Intervention Type DRUG

Entecavir 0.5mg orally daily

Lamivudine

Switch to lamivudine 100mg daily

Group Type ACTIVE_COMPARATOR

Lamivudine

Intervention Type DRUG

Lamivudine 100mg orally, daily

Interventions

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Entecavir

Entecavir 0.5mg orally daily

Intervention Type DRUG

Lamivudine

Lamivudine 100mg orally, daily

Intervention Type DRUG

Other Intervention Names

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Baraclude Zeffix

Eligibility Criteria

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Inclusion Criteria

* Patients with chronic hepatitis B treated with entecavir for 6 months or more
* Normal ALT
* Undetectable HBV DNA by Roche Taqman PCR Assay
* No other previous therapy with nucleoside/nucleotide analogues

Exclusion Criteria

* Presence of other liver diseases including hepatitis C co-infection, autoimmune hepatitis , primary biliary cirrhosis, primary sclerosing cholangitis, alcoholic liver disease, and Wilson's disease
* History of hepatocellular carcinoma
* History of decompensated liver disease
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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James Yan Yue Fung

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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James Fung, MBChB

Role: PRINCIPAL_INVESTIGATOR

The University of Hong Kong

Locations

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The University of Hong Kong

Hong Kong, , China

Site Status

Countries

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China

Other Identifiers

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HKUHEP-01

Identifier Type: -

Identifier Source: org_study_id