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

A Multicenter, Randomized, Controlled Tial of Combination Therapy for Lamivudine-resistant Chronic Hepatitis B Patient: Comparing Clevudine Plus Adefovir With Lamivudine Plus Adefovir

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00798460

Enrollment

Registered

2008-11-26

Start date

2008-12-31

Completion date

2010-11-30

Last updated

2011-06-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Hepatitis B

Keywords

Chronic hepatitis B, lamivudine resistance, clevudine

Brief summary

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

Detailed description

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.

Interventions

DRUGadefovir

adefovir 10mg

DRUGclevudine

clevudine 30mg

DRUGlamivudine

lamivudine 100mg

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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%

Design outcomes

Primary

Measure	Time frame
HBV DNA titer < 300 copies/mL	48 week

Secondary

Measure	Time frame
Normalization of serum ALT, loss of HBeAg and HBsAg, incidence of adefovir resistance	48 week

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026