Efficacy of Clevudine Plus Lamivudine for Lamivudine-resistant Chronic Hepatitis B Patients

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

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Study Completion Date

2010-11-30

Brief Summary

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The purpose of this study is to determine the optimal antiviral treatment for lamivudine resistant hepatitis B patients.

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Detailed Description

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Lamivudine with adefovir combination therapy has been known as effective antiviral therapy for lamivudine resistant chronic hepatitis B patients. It is superior to adefovir monotherapy since the incidence of viral breakthrough of combination therapy used to be less than that of adefovir monotherapy in lamivudine resistant chronic hepatitis B patients. Clevudine, which is being marketed in Korea, is a nucleoside analogue of the unnatural beta-L configuration that has potent activity against HBV. It has demonstrated potent antiviral efficacy and significant biochemical improvement after 24 weeks of therapy. We hypothesized that clevudine plus adefovir combination therapy for lamivudine resistant patients might be as effective as the lamivudine plus adefovir combination therapy.

In detail, we designed to perform this clinical study comparing the combination of clevudine and adefovir with lamivudine plus adefovir in lamivudine resistant chronic hepatitis B patient. Total treatment duration of both groups will be 12 months, and compare the efficacy of antiviral effects of these drugs.

Conditions

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Chronic Hepatitis B

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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Lamivudine plus adefovir

Group Type ACTIVE_COMPARATOR

adefovir

Intervention Type DRUG

adefovir 10mg

lamivudine

Intervention Type DRUG

lamivudine 100mg

Clevudine plus adefovir

Group Type ACTIVE_COMPARATOR

adefovir

Intervention Type DRUG

adefovir 10mg

clevudine

Intervention Type DRUG

clevudine 30mg

Interventions

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adefovir

adefovir 10mg

Intervention Type DRUG

clevudine

clevudine 30mg

Intervention Type DRUG

lamivudine

lamivudine 100mg

Intervention Type DRUG

Other Intervention Names

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Hepsera Levovir Zeffix

Eligibility Criteria

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Inclusion Criteria

* HBsAg positive and anti-HBs negative more than 6 months
* YMDD mutation (+)during lamivudine therapy
* Serum ALT more than two times upper normal value

Exclusion Criteria

* HAV IgM Ab + and/or HCV Ab+ and/or HDV Ab and/or HIV Av+
* The sign of decompensated liver disease
* Pregnant or lactating woman
* The history of hemoglobinopathy, autoimmune hepatitis, alcoholic liver disease
* Hemoglobin less than 8 g/dL (male), 7.5g/dL (female) or neutrophil count less than 1500/mm3 or platelet count less than 50,000/mm3
* Serum creatinine more than 1.5 times upper normal limit value
* The sign of malignancy or suggestive of malignancy or the history of malignancy, the recurrence rate within 2 years of which is more than 20%

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No