Efficacy and Safety of Telbivudine 600mg Tablets in Chinese Patients With Chronic Hepatitis B
NCT ID: NCT00781105
Last Updated: 2017-02-23
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
2200 participants
INTERVENTIONAL
2008-08-01
2010-09-16
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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1
Telbivudine
600 mg/day, oral tablets, once daily, 52 weeks
Interventions
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Telbivudine
600 mg/day, oral tablets, once daily, 52 weeks
Eligibility Criteria
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Inclusion Criteria
* Documented CHB defined by detectable serum HBsAg and serum HBV DNA level
* Willing and able to comply with the study drug regimen
* Written informed consent before any assessment
Exclusion Criteria
* Patient has a history of HCC or findings suggestive of possible HCC
* Patient has received treatment of nucleoside or nucleotide drugs whether approved or investigational at any time
* History of hypersensitivity to any of the drugs (telbivudine) or to drugs of similar clinical classes
* Patient has received IFN or other immunomodulatory treatment with 12 months before screening
* Previous treatment history with NRTIs
16 Years
65 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Jia Jidong, Dr.
Role: PRINCIPAL_INVESTIGATOR
Beijing Friendship Hospital
Locations
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Novartis Investigative Site
Beijing, , China
Countries
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Other Identifiers
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CLDT600ACN03
Identifier Type: -
Identifier Source: org_study_id
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