Switching Study From Lamivudine to Clevudine in the Chronic Hepatitis B Patients
NCT ID: NCT00558493
Last Updated: 2012-07-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
100 participants
INTERVENTIONAL
2007-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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1
switching treatment from lamivudine to clevudine
Clevudine
clevudine 30 mg qd for 24 seeks
Interventions
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Clevudine
clevudine 30 mg qd for 24 seeks
Eligibility Criteria
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Inclusion Criteria
* 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
* 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 \[kg\])\] / \[(72) (serum creatinine\] \[mg/dL\])\[Note: multiply estimates by 0.85 for women\]
18 Years
60 Years
ALL
No
Sponsors
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Bukwang Pharmaceutical
INDUSTRY
Locations
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Youngnam University Medical Center
Daegu, , South Korea
Countries
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Other Identifiers
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KB-406
Identifier Type: -
Identifier Source: secondary_id
KB-406
Identifier Type: -
Identifier Source: org_study_id