Switching Study From Lamivudine to Clevudine in the Chronic Hepatitis B Patients

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

A multi-center and open study to compare the safety and effectiveness of switching treatment from lamivudine to clevudine for 24 weeks.

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

Details

• Lead Sponsor: Bukwang Pharmaceutical
• Treatments: Clevudine; Lamivudine

Criteria

Inclusion Criteria:

• HBV DNA > 2,000 copies/mL at screening

• Patients who have compensated liver disease (Child-Pugh score =<6)

• Patients without LMV resistant mutation by RFMP assay

• Patients who have NOT experienced viral breakthrough at consecutive two measurements (at least one month apart) during lamivudine monotherapy

• Patients who can submit the written consent and comply with the claims postulated of this clinical trial

Exclusion Criteria:

• Currently receiving antiviral except LMV or corticosteroid therapy

• Patients that previously received antiviral treatment for hepatitis B other than lamivudine in the proceeding 12 months

• Previous treatment with interferon or other immunomodulatory therapies must have ended at least 6 months preceding the study screening

• Treatment with nephrotoxic drugs, competitors of renal excretion, and/or hepatotoxic drugs within 2 months before study screening or during the study period

• Patients who is co-infected with HCV, HDV or HIV

• Serious concurrent medical conditions

• Prior organ transplantation

• Patient has creatinine clearance less than 60mL/min as estimated by the following formula:

[(140-age in years) (body weight [kg])] / [(72) (serum creatinine] [mg/dL])[Note: multiply estimates by 0.85 for women]