Telbivudine Renoprotective Effect in Patients With HBV-related Liver Cirrhosis
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|ClinicalTrials.gov Identifier: NCT01693679|
Recruitment Status : Unknown
Verified September 2012 by Shao-quan Zhang, Sun Yat-sen University.
Recruitment status was: Active, not recruiting
First Posted : September 26, 2012
Last Update Posted : September 26, 2012
Information provided by (Responsible Party):
Shao-quan Zhang, Sun Yat-sen University
• To estimate renoprotective efficacy of Telbivudine treated patients with HBV-related liver cirrhosis.
|Condition or disease||Intervention/treatment||Phase|
|HBV-related Liver Cirrhosis||Drug: Telbivudine, Lamivudine, Adefovir ,Enecavir||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||September 2012|
|Estimated Primary Completion Date :||April 2014|
Experimental: 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.
Drug: Telbivudine, Lamivudine, Adefovir ,Enecavir
investigational Telbivudine,600mg,daily,oral.comparator Lamivudine,100mg daily, oral,Adefovir,10mg,daily,oral,Enecavir,0.5mg,daily,oral.
Other Name: no.
Primary Outcome Measures :
- Change from Baseline in glomerular filtration rate and Serum creatinine at 96 weeks [ Time Frame: May 2014 ]No.
Secondary Outcome Measures :
- Change from Baseline in ALT normalization rate,• The rate of complications,• Percentage of participants with HBeAg loss & HBeAg seroconversion and Percentage of subjects achieving HBV DNA<300copies/mL at96 weeks [ Time Frame: May 2014 ]No.
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