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Replacement of Lamivudine by Telbivudine to Improve Renal Function

Sponsor
Chang Gung Memorial Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT02447705
Collaborator
(none)
120
Enrollment
2
Arms
44
Duration (Months)

Study Details

Study Description

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
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.

Study Design

Study Type:
Interventional
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 :
Jun 1, 2013
Actual Primary Completion Date :
Dec 31, 2016
Actual Study Completion Date :
Jan 31, 2017

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Lamivudine group

continue Lamivudine
Experimental: Telbivudine group

Telbivudine replaces Lamivudine

Drug: telbivudine
telbivudine replace Lamivudine
Other Names:
  • sobivo

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Renal function measurement [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 [every 6 months, up to 12 months]

      Measure hepatitis B surface antigen every 6 months. If HBs AG appears, hepatitis B recurrence is diagnosed.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    16 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Chang Gung Memorial Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Chang Gung Memorial Hospital
    ClinicalTrials.gov Identifier:
    NCT02447705
    Other Study ID Numbers:
    • CGMH-IRB-101-3476A3
    First Posted:
    May 19, 2015
    Last Update Posted:
    Feb 7, 2017
    Last Verified:
    Mar 1, 2013
    Additional relevant MeSH terms:
    Virus Diseases
    Telbivudine

    Study Results

    No Results Posted as of Feb 7, 2017