NCT02447705

Replacement of Lamivudine by Telbivudine to Improve Renal Function

Replacement of Lamivudine by Telbivudine to Improve Renal Function for Post-transplant Hepatitis B Patients - a Randomized Clinical Trial

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Chang Gung Memorial Hospital · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Disorder Related to Transplantation
• Virus Diseases
• Injury Due to Exposure to External Cause

Interventions

Type	Name	Description
DRUG	telbivudine	telbivudine replace Lamivudine

Timeline

• Start date: 2013-06-01
• Primary completion: 2016-12-31
• Completion: 2017-01-31
• First posted: 2015-05-19
• Last updated: 2017-02-07