Efficacy Study of Telbivudine in Chronic Hepatitis B Patients
NCT ID: NCT01958229
Last Updated: 2013-10-09
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
23 participants
OBSERVATIONAL
2009-12-31
2013-04-30
Brief Summary
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Detailed Description
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Study purpose:
This study is designed to evaluate the efficacy of telbivudine in real-life clinical settings with the use of the Roadmap Concept in chronic hepatitis B treatment.
Objectives:
Primary:
To observe telbivudine's 2-year efficacy in real-world clinical setting of achieving HBV-DNA \< 60 IU/ml and HBeAg seroconversion rate in patients with defined baseline characteristics and 24-week treatment PCR negativity as previously reported in GLOBE study's sub-analysis.
Secondary:
1. To observe the treatment outcomes.
2. To validate the result of super-responder trial.
3. To validate the Roadmap Concept.
Population:
The study population will consist of a representative group of 500 chronic hepatitis B patients with detectable HBsAg for more than 6 months who need telbivudine therapy based on investigators' judgment in 16 medical centers located in Taiwan.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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CHB patients without cirrhosis
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Documented chronic hepatitis B defined by ALL of following:
1. Clinical history compatible with compensated chronic hepatitis B
2. Detectable serum hepatitis B surface antigen (HBsAg)\> 6 months and at the screening visit.
Exclusion Criteria
* co-infection with hepatitis C virus (HCV) or HIV
* Clinical or imaging diagnosis of cirrhosis
* Evidence of decreased renal function of creatinine \>(=)2x ULN
18 Years
65 Years
ALL
No
Sponsors
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National Taiwan University Hospital
OTHER
Responsible Party
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Principal Investigators
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Jia-Horng Kao, Professor
Role: PRINCIPAL_INVESTIGATOR
National Taiwan University Hospital
Locations
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National Taiwan University Hospital
Taipei, , Taiwan
Countries
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Other Identifiers
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200910027M
Identifier Type: -
Identifier Source: org_study_id