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

Phase 4TerminatedNCT00798460

Inje University30 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Chronic Hepatitis B

Interventions

adefovirDRUG

adefovir 10mg

clevudineDRUG

clevudine 30mg

lamivudineDRUG

lamivudine 100mg

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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%

Locations (1)

Ilsanpaik hospital

Goyang, Gyunggi, South Korea

Outcomes

Primary Outcomes

HBV DNA titer < 300 copies/mL

Time frame: 48 week

Secondary Outcomes

Normalization of serum ALT, loss of HBeAg and HBsAg, incidence of adefovir resistance

Time frame: 48 week

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.