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

Chronic Hepatitis B Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00558493
• Other study ID #: KB-406
• Secondary ID: KB-406
• Status: Completed
• Phase: Phase 4
• First received: November 14, 2007
• Last updated: July 24, 2012
• Start date: November 2007

Study information

• Verified date: July 2012
• Source: Bukwang Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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]

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Hepatitis B
• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• Clevudine
clevudine 30 mg qd for 24 seeks

Locations

Country	Name	City	State
Korea, Republic of	Youngnam University Medical Center	Daegu

Sponsors (1)

Lead Sponsor	Collaborator
Bukwang Pharmaceutical

Country where clinical trial is conducted

Korea, Republic of,