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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
Sponsor:
Information provided by (Responsible Party):
Chang Gung Memorial Hospital

Brief 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.

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

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Lamivudine group
continue Lamivudine
Experimental: Telbivudine group
Telbivudine replaces Lamivudine
Drug: telbivudine
telbivudine replace Lamivudine
Other Name: sobivo




Primary Outcome Measures :
  1. 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 :
  1. 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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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Exclusion Criteria:

  1. Acute rejection with increase CNI dose within a month.
  2. Pregnant or nursing.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT02447705     History of Changes
Other Study ID Numbers: CGMH-IRB-101-3476A3
First Posted: May 19, 2015    Key Record Dates
Last Update Posted: February 7, 2017
Last Verified: March 2013

Additional relevant MeSH terms:
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Lamivudine
Virus Diseases
Telbivudine
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Anti-HIV Agents