Prospective Exploratory Study to Describe Hepatitis B Virus (HBV) Kinetics During Treatment With Telbivudine
NCT ID: NCT00640588
Last Updated: 2017-03-28
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
PHASE3
30 participants
INTERVENTIONAL
2008-03-31
2009-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
OTHER
NONE
Study Groups
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1
Telbivudine
Telbivudine
Arm 1: 600 mg/day, oral telbivudina for 24 weeks
2
Arm 2: 600 mg/day, oral telbivudina plus 10 mg/day oral adefovir for 24 weeks
oral adefovir
Arm 2: 600 mg/day, oral telbivudina plus 10 mg/day oral adefovir for 24 weeks
Interventions
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Telbivudine
Arm 1: 600 mg/day, oral telbivudina for 24 weeks
oral adefovir
Arm 2: 600 mg/day, oral telbivudina plus 10 mg/day oral adefovir for 24 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Documented compensated HBeAg negative CHB defined by baseline HBV serology, DNA and ALT criteria.
Exclusion Criteria
* Prior therapy with nucleos(t)ides in NAÏVE patient and prior treatment with lamivudine in patients with suboptimal response to adefovir.
* History of hepatic decompensation
* History of malignancy
* Patient has one or more additional known primary or secondary causes of liver disease
18 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis
Role: STUDY_DIRECTOR
Novartis
Locations
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Novartis Investigative Site
Barcelona, , Spain
Countries
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Other Identifiers
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CLDT600AES01
Identifier Type: -
Identifier Source: org_study_id
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