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| Name | Class |
|---|---|
| Novartis | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Telbivudine | Experimental | Telbivudine,600mg/d,oral,100patients,2 years. |
|
| Adefovir | Experimental | Adefovir,10mg/d,oral,100 patients,2years. |
|
| Enecavir | Experimental | Enecavir,0.5mg/d,oral,100 patients,2 year |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telbivudine | Drug | 600 mg monotherapy supplied in film-coated tablets. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change of estimate of glomerular filtration rate (eGFR)* and Serum creatinine in week 4,12,18,24,48,72,96 in each Group. | NO. | up to 2years |
| Measure | Description | Time Frame |
|---|---|---|
| Liver function change (ALB/GLB, ALT/AST, TB) in each Group | up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of subjects with ALT normalization rate at year 1and year 2 in each Group. | up to 2 years | |
| The rate of complications (ascites, hepatorenal syndrome and so on) | up to 2 years |
Inclusion Criteria:Subjects eligible for enrolment in the study must meet all of the following criteria:
Exclusion Criteria:
Subjects meeting any of the following criteria must not be enrolled in the study
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| Name | Affiliation | Role |
|---|---|---|
| Lin Bingliang, PhD | Department of Infectious Diseases, The Third Affiliated Hospital of Sun Yat-sen University | Study Chair |
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| ID | Term |
|---|---|
| D008103 | Liver Cirrhosis |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D000077712 | Telbivudine |
| C053001 | adefovir |
| ID | Term |
|---|---|
| D013936 | Thymidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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| Enecavir | Drug | 0.5 mg monotherapy supplied in tablets. |
|
|
| Adefovir | Drug | 10 mg monotherapy supplied in tablets. |
|
|
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D006571 |
| Heterocyclic Compounds |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |