Comparison of Telbivudine Versus Lamivudine on the Early Dynamics and Kinetics of Viral Suppression in Chronic Hepatitis B
NCT ID: NCT00710216
Last Updated: 2009-04-20
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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WITHDRAWN
PHASE4
40 participants
INTERVENTIONAL
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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A
Lamivudine
100 mg/day
B
Telbivudine
600 mg/day
Interventions
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Lamivudine
100 mg/day
Telbivudine
600 mg/day
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Increased viral load with a concentration of serum HBV-DNA of at least 10\^4 copies/ml
* Proof of inflammatory activity in the liver: ALT ≥ 2 x ULN or histological evidence of inflammatory activity ≥ level I or fibrosis of ≥ I degrees (according to the Desmet classification)
* Negative urine pregnancy test with fertile women
* Willingness to use a recognized method of contraception
* Able to comply with study regimen and provide written informed consent
Exclusion Criteria
* Known hypersensitivity to lamivudine or telbivudine or any of the other components of the preparations
* Pregnant or breastfeeding women or women
* Simultaneous participation in other clinical trials or in the past three months
* Co-infected with HCV, HDV, HIV
* Other non HBV-related chronic liver disease: Autoimmune hepatitis, primary biliary cirrhosis, Hemochromatosis, alpha-1 antitrypsin deficiency, alcoholic hepatitis
* Evidence of hepatocellular carcinoma (alpha-fetoprotein levels\> 100 ng/ml)
* Active drug use, including an excessive alcohol consumption during the last 6 months before participating in the clinical trial
* Use of systemic treatment with anti-neoplastic or immunomodulatory medication within the last 6 months before participating in the clinical trial and during the duration of the clinical examination
* Lack of willingness or inability to consent in writing
* Concurrent condition likely to preclude compliance with schedule of evaluations
18 Years
70 Years
ALL
No
Sponsors
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Novartis
INDUSTRY
University of Ulm
OTHER
Responsible Party
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Universitätsklinikum Ulm
Principal Investigators
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Nektarios Dikopoulos, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital Ulm
Locations
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University Hospital Ulm
Ulm, , Germany
Countries
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Related Links
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University Hospital Ulm
Other Identifiers
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EVD-001
Identifier Type: -
Identifier Source: org_study_id
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