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

Sponsor

Bukwang Pharmaceutical (Industry)

Overall Status

Completed

CT.gov ID

NCT00558493

Collaborator

(none)

100

Enrollment

Location

Arm

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Chronic Hepatitis B	Drug: Clevudine	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Phase lV Study to Evaluate the Safety and Effectiveness of Switching Treatment From Lamivudine to Clevudine in the Chronic Hepatitis B Patients With Suboptimal Virologic Response During Lamivudine Treatment

Study Start Date :

Nov 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 switching treatment from lamivudine to clevudine	Drug: Clevudine clevudine 30 mg qd for 24 seeks

Arm

Intervention/Treatment

Experimental: 1

switching treatment from lamivudine to clevudine

Drug: Clevudine

clevudine 30 mg qd for 24 seeks

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts 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: