Telbivudine Renoprotective Effect in Patients With the HBV-related Liver Cirrhosis: a Randomized Controlled Trial
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|ClinicalTrials.gov Identifier: NCT01799486|
Recruitment Status : Unknown
Verified February 2013 by Lin Bingliang, Sun Yat-sen University.
Recruitment status was: Active, not recruiting
First Posted : February 26, 2013
Last Update Posted : February 26, 2013
Chronic hepatitis B virus (HBV) infection is a serious clinical problem because of its worldwide distribution and potential adverse outcome, including cirrhosis, which is a major cause of HBV related death. Studies show the use of nucleot(s)ide analogs treatment can alleviate, even reverse the progress of HBV-related cirrhosis. In cirrhosis stage, some potential factors, including endocrine disorder, renin, aldosterone, vasopressin increasing, hepatitis B virus related nephritis, hepatorenal syndrome, may cause renal damage. With the exposure of NAs, adverse reports of rhabdomyolysis, renal dysfunction, and lactic acidosis are increasing. So when choosing NAs, the potential renal function impairment should be considered.
Recently, Gane, Xiaoxi Li have separately reported that Telbivudine can improve estimate of glomerular filtration rate (eGFR) of patients with chronic hepatitis B, while eGFR of patients with Lamivudine, adefovir and entecavir have a trend of decrease, which suggested Telbivudine may have renal protective effects. This effect on patients with HBV-related liver cirrhosis has not been studied, which is not clear now.
This study is a randomized controlled study to prospectively observe Telbivudine's effect on renal function, which aims to provide evidence in antiviral treatment for the patients with cirrhosis.
|Condition or disease||Intervention/treatment||Phase|
|HBV-related Liver Cirrhosis||Drug: Telbivudine Drug: Enecavir Drug: Adefovir||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Telbivudine Renoprotective Effect in Patients With the HBV-related Liver Cirrhosis: a Randomized Controlled Trial|
|Study Start Date :||February 2013|
|Actual Primary Completion Date :||February 2013|
|Estimated Study Completion Date :||March 2015|
600 mg monotherapy supplied in film-coated tablets.
Other Name: No.
0.5 mg monotherapy supplied in tablets.
Other Name: No.
Enecavir,0.5mg/d,oral,100 patients,2 year
10 mg monotherapy supplied in tablets.
Other Name: No.
- Change of estimate of glomerular filtration rate (eGFR)* and Serum creatinine in week 4,12,18,24,48,72,96 in each Group. [ Time Frame: up to 2years ]NO.
- Liver function change (ALB/GLB, ALT/AST, TB) in each Group [ Time Frame: up to 2 years ]
- Percentage of subjects with ALT normalization rate at year 1and year 2 in each Group. [ Time Frame: up to 2 years ]
- The rate of complications (ascites, hepatorenal syndrome and so on) [ Time Frame: up to 2 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01799486
|Study Chair:||Lin Bingliang, PhD||Department of Infectious Diseases, The Third Affiliated Hospital of Sun Yat-sen University|