Replacement of Lamivudine by Telbivudine to Improve Renal Function

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2017-01-31

Brief Summary

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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.

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Detailed Description

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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

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Lamivudine group

continue Lamivudine

Group Type NO_INTERVENTION

No interventions assigned to this group

Telbivudine group

Telbivudine replaces Lamivudine

Group Type EXPERIMENTAL

telbivudine

Intervention Type DRUG

telbivudine replace Lamivudine

Interventions

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telbivudine

telbivudine replace Lamivudine

Intervention Type DRUG

Other Intervention Names

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sobivo

Eligibility Criteria

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Inclusion Criteria

1. Sign inform consent
2. Age is not less than 16 years old.
3. Post liver transplantation patient for HBV-related indication.
4. Chronic hepatitis B transplant patients who are treated by lamivudine for not less than 6 months.
5. eGRF stage 2-4 patients (15\<eGFR\<90ml)
6. Stable liver function, ALT not more than 2 folds of upper limit.