Efficacy and Safety of Telbivudine in Patients With Chronic Hepatitis B
NCT ID: NCT00606099
Last Updated: 2012-05-02
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WITHDRAWN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
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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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
telbivudine
telbivudine
To compare the rate and pattern of treatment-emergent Hepatitis B virus (HBV) viral genotypic mutations after 24 weeks of treatment.
2
adefovir dipivoxil
adefovir dipivoxil
Active Comparator
Interventions
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telbivudine
To compare the rate and pattern of treatment-emergent Hepatitis B virus (HBV) viral genotypic mutations after 24 weeks of treatment.
adefovir dipivoxil
Active Comparator
Eligibility Criteria
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Inclusion Criteria
* Patients with compensated chronic hepatitis B who are currently receiving adefovir 10mg once daily.
* Patients must have received adefovir 10mg once daily for at least 48 weeks continuously and have a sub-optimal response to adefovir therapy (≥4log10 copies of HBV DNA/mL).
* Patient is willing to comply with all study requirements.
* Patient is willing and able to provide written informed consent.
Exclusion Criteria
* Female patients of reproductive potential is unwilling to use double barrier method of contraception (condom plus spermicide or diaphragm plus spermicide).
* Patient is co-infected with hepatitis C virus or HIV.
* Patient has previously taken lamivudine.
* Patient is currently abusing illicit drugs or alcohol.
* Patient is using any investigational drugs or with in the last 30 days.
* Patient is enrolled or plans to enroll in a clinical study involving investigational drug.
* Patient has a history of pancreatitis, hepatic decompsensation, Hepatocellular Carcinoma, or a history of hypersensitivity to telbivudine or adfovir.
18 Years
ALL
No
Sponsors
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Novartis
INDUSTRY
Responsible Party
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Locations
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Novartis
Atlanta, Georgia, United States
Novartis
Flushing, New York, United States
Novartis
Sterling, Virginia, United States
Countries
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Other Identifiers
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CLDT600AUS03
Identifier Type: -
Identifier Source: org_study_id
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