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Telbivudine Renoprotective Effect in Patients With HBV-related Liver Cirrhosis

Primary Purpose

HBV-related Liver Cirrhosis

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Telbivudine, Lamivudine, Adefovir ,Enecavir
Sponsored by
Shao-quan Zhang
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HBV-related Liver Cirrhosis focused on measuring Tebivudine eGFR non-Tebivudine

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Subjects eligible for enrolment in the study must meet all of the following criteria:

  • Aged between 18-75 years (inclusive).
  • Male or female.
  • Subjects with positive HBsAg for more than 6 months and anti-HBs negative regardless of HBeAg status , HBV DNA ≥2×103 IU/ml
  • Subjects with HBV-related liver cirrhosis, including compensated cirrhosis and decompensated, but only Child-Pugh A or B.
  • The ablility to understand and sign a written informed consent prior to any study related procedure and comply with the requirements of the study.

Exclusion Criteria:

  • Subjects meeting any of the following criteria must not be enrolled in the study

    • Subjects with non-HBV cirrhosis
    • Co-infection with HAV/HCV/HDV/ HIV
    • Subjects who take nucleosides within 6 months
    • Kidney injury due to non-HBV factors
    • Inability to comply with study requirements as determined by the study investigator
    • Patients with very low GFR, who may need dialysis or renal transplantation

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    antiviral drug

    Arm Description

    Telbivudine team,Telbivudine,600mg/d,oral,60 patients. non-Tebivudine team,Lamivudine,100mg/d,oral,20 patients.Adefovir,10mg/d,oral,20 patients.Enecavir,0.5mg/d,oral,20 patients.

    Outcomes

    Primary Outcome Measures

    Change from Baseline in glomerular filtration rate and Serum creatinine at 96 weeks
    No.

    Secondary Outcome Measures

    Change from Baseline in ALT normalization rate,• The rate of complications,• Percentage of participants with HBeAg loss & HBeAg seroconversion and Percentage of subjects achieving HBV DNA<300copies/mL at96 weeks
    No.

    Full Information

    First Posted
    September 20, 2012
    Last Updated
    September 24, 2012
    Sponsor
    Shao-quan Zhang
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01693679
    Brief Title
    Telbivudine Renoprotective Effect in Patients With HBV-related Liver Cirrhosis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2012
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 2012 (undefined)
    Primary Completion Date
    April 2014 (Anticipated)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Shao-quan Zhang

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    • To estimate renoprotective efficacy of Telbivudine treated patients with HBV-related liver cirrhosis.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    HBV-related Liver Cirrhosis
    Keywords
    Tebivudine eGFR non-Tebivudine

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    120 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    antiviral drug
    Arm Type
    Experimental
    Arm Description
    Telbivudine team,Telbivudine,600mg/d,oral,60 patients. non-Tebivudine team,Lamivudine,100mg/d,oral,20 patients.Adefovir,10mg/d,oral,20 patients.Enecavir,0.5mg/d,oral,20 patients.
    Intervention Type
    Drug
    Intervention Name(s)
    Telbivudine, Lamivudine, Adefovir ,Enecavir
    Other Intervention Name(s)
    no.
    Intervention Description
    investigational Telbivudine,600mg,daily,oral.comparator Lamivudine,100mg daily, oral,Adefovir,10mg,daily,oral,Enecavir,0.5mg,daily,oral.
    Primary Outcome Measure Information:
    Title
    Change from Baseline in glomerular filtration rate and Serum creatinine at 96 weeks
    Description
    No.
    Time Frame
    May 2014
    Secondary Outcome Measure Information:
    Title
    Change from Baseline in ALT normalization rate,• The rate of complications,• Percentage of participants with HBeAg loss & HBeAg seroconversion and Percentage of subjects achieving HBV DNA<300copies/mL at96 weeks
    Description
    No.
    Time Frame
    May 2014

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Subjects eligible for enrolment in the study must meet all of the following criteria: Aged between 18-75 years (inclusive). Male or female. Subjects with positive HBsAg for more than 6 months and anti-HBs negative regardless of HBeAg status , HBV DNA ≥2×103 IU/ml Subjects with HBV-related liver cirrhosis, including compensated cirrhosis and decompensated, but only Child-Pugh A or B. The ablility to understand and sign a written informed consent prior to any study related procedure and comply with the requirements of the study. Exclusion Criteria: Subjects meeting any of the following criteria must not be enrolled in the study Subjects with non-HBV cirrhosis Co-infection with HAV/HCV/HDV/ HIV Subjects who take nucleosides within 6 months Kidney injury due to non-HBV factors Inability to comply with study requirements as determined by the study investigator Patients with very low GFR, who may need dialysis or renal transplantation

    12. IPD Sharing Statement

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