Replacement of Lamivudine by Telbivudine to Improve Renal Function
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|ClinicalTrials.gov Identifier: NCT02447705|
Recruitment Status : Completed
First Posted : May 19, 2015
Last Update Posted : February 7, 2017
Chang Gung Memorial Hospital
Information provided by (Responsible Party):
Chang Gung Memorial Hospital
Nephrotoxicity is one of the adverse effects of lamivudine and dosage of lamivudine has to be reduced if patients' renal function is insufficiency. Telbivudine may improve glomerular filtration rate. This study is to see whether renal function is improved when Lamivudine is replaced by telbivudine in liver transplantation patients.
|Condition or disease||Intervention/treatment||Phase|
|Disorder Related to Transplantation Virus Diseases Injury Due to Exposure to External Cause||Drug: telbivudine||Phase 2 Phase 3|
Liver transplantation is the only effective treatment for the patients with liver failure. Hepatitis B-related liver cirrhosis is the major indication to have liver transplantation in Taiwan. After liver transplantation, prophylaxis of hepatitis B recurrence will be performed by anti-hepatitis B immunoglobulin and anti-viral agents. Currently, lamivudine is the drug the investigators choose to prevent HBV recurrence for many years because it is safe for long-term use. However, nephrotoxicity is one of the adverse effects of lamivudine and dosage of lamivudine has to be reduced if patients' renal function is insufficiency. Recently, the studies on chronic hepatitis B patients showed improvement of glomerular filtration rate for those receiving telbivudine treatment. In this study, the investigators will include our post-transplant HBV patients who have stable liver function, receive lamivudine for prophylaxis of recurrent hepatitis B, and have renal dysfunction in stage II-IV. The patients will be randomized to receive telbivudine or lamivudine continuously at 1:1 ratio. Renal function will be examined at 6 months interval to determine whether renal function is improved. The achievement will determine whether telbivudine is better than lamivudine for the HBV patients with renal dysfunction.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Replacement of Lamivudine by Telbivudine to Improve Renal Function for Post-transplant Hepatitis B Patients - a Randomized Clinical Trial|
|Study Start Date :||June 2013|
|Actual Primary Completion Date :||December 31, 2016|
|Actual Study Completion Date :||January 31, 2017|
No Intervention: Lamivudine group
Experimental: Telbivudine group
Telbivudine replaces Lamivudine
telbivudine replace Lamivudine
Other Name: sobivo
Primary Outcome Measures :
- Renal function measurement [ Time Frame: every 2 months, up to 12 months ]Measure eGFR when the patients were enrolled, every 2 months and up to 12 months. The most important time point will be to compare eGRF at 6 month and 12 months after medication conversion to the beginning levels. Renal function is improved if eGRF is better after medication conversion.
Secondary Outcome Measures :
- hepatitis B recurrence [ Time Frame: every 6 months, up to 12 months ]Measure hepatitis B surface antigen every 6 months. If HBs AG appears, hepatitis B recurrence is diagnosed.
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