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

Bukwang Pharmaceutical

Status and phase

Completed

Phase 4

Conditions

Chronic Hepatitis B

Treatments

Drug: Clevudine

Study type

Interventional

Funder types

Industry

Identifiers

KB-406

Details and patient eligibility

About

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

Enrollment

100 estimated patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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]