Telbivudine Renoprotective Effect in Patients With HBV-related Liver Cirrhosis
NCT ID: NCT01693679
Last Updated: 2012-09-26
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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UNKNOWN
PHASE4
120 participants
INTERVENTIONAL
2012-09-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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antiviral drug
Telbivudine team,Telbivudine,600mg/d,oral,60 patients. non-Tebivudine team,Lamivudine,100mg/d,oral,20 patients.Adefovir,10mg/d,oral,20 patients.Enecavir,0.5mg/d,oral,20 patients.
Telbivudine, Lamivudine, Adefovir ,Enecavir
investigational Telbivudine,600mg,daily,oral.comparator Lamivudine,100mg daily, oral,Adefovir,10mg,daily,oral,Enecavir,0.5mg,daily,oral.
Interventions
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Telbivudine, Lamivudine, Adefovir ,Enecavir
investigational Telbivudine,600mg,daily,oral.comparator Lamivudine,100mg daily, oral,Adefovir,10mg,daily,oral,Enecavir,0.5mg,daily,oral.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Aged between 18-75 years (inclusive).
* Male or female.
* Subjects with positive HBsAg for more than 6 months and anti-HBs negative regardless of HBeAg status , HBV DNA ≥2×103 IU/ml
* Subjects with HBV-related liver cirrhosis, including compensated cirrhosis and decompensated, but only Child-Pugh A or B.
* The ablility to understand and sign a written informed consent prior to any study related procedure and comply with the requirements of the study.
Exclusion Criteria
* Subjects with non-HBV cirrhosis
* Co-infection with HAV/HCV/HDV/ HIV
* Subjects who take nucleosides within 6 months
* Kidney injury due to non-HBV factors
* Inability to comply with study requirements as determined by the study investigator
* Patients with very low GFR, who may need dialysis or renal transplantation
18 Years
75 Years
ALL
No
Sponsors
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Shao-quan Zhang
OTHER
Responsible Party
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Shao-quan Zhang
Department of Infectious Diseases, The Third Affiliated Hospital of Sun Yat-sen University
Other Identifiers
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Telbivudine
Identifier Type: -
Identifier Source: org_study_id