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

• Status: Terminated
• Trial end date: 2010-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Inje University
• Collaborator: Bukwang Pharmaceutical
• Treatments: Adefovir; Adefovir dipivoxil; Clevudine; Lamivudine

Criteria

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%