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

Primary Purpose

Chronic Hepatitis B

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Clevudine
Sponsored by
Bukwang Pharmaceutical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Hepatitis B

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept 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]

Sites / Locations

  • Youngnam University Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

switching treatment from lamivudine to clevudine

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 14, 2007
Last Updated
July 24, 2012
Sponsor
Bukwang Pharmaceutical
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1. Study Identification

Unique Protocol Identification Number
NCT00558493
Brief Title
Switching Study From Lamivudine to Clevudine in the Chronic Hepatitis B Patients
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 Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Bukwang Pharmaceutical

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis B

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
switching treatment from lamivudine to clevudine
Intervention Type
Drug
Intervention Name(s)
Clevudine
Intervention Description
clevudine 30 mg qd for 24 seeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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]
Facility Information:
Facility Name
Youngnam University Medical Center
City
Daegu
Country
Korea, Republic of

12. IPD Sharing Statement

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

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