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Tenofovir Monotherapy in Patients With Chronic Hepatitis B Patients Who Had Achieved Complete Viral Suppression on Lamivudine Plus Adefovir

Primary Purpose

Proportion of Patients With a Sustained Virological Response (Serum HBV DNA <20 IU/mL) at Week 48

Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
lamivudine plus adefovir combination
Tenofovir Disoproxil Fumarate
Sponsored by
Uijeongbu St. Mary Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Proportion of Patients With a Sustained Virological Response (Serum HBV DNA <20 IU/mL) at Week 48

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • HBsAg (+) for > 6 months age >19 years antiviral resistance to LAM (rtL180M and/or M204V/I) currently receiving LAM plus ADV for more than 12 months HBV DNA levels <20 IU/ml on two consecutive tests of 3-month interval

Exclusion Criteria:

  • Cr ≥1.5 mg/dL Evidence of decompensated liver disease Malignant neoplasm Coinfection with HIV, HCV

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    lamivudine adefovir

    tenofovir

    Arm Description

    Outcomes

    Primary Outcome Measures

    SVR
    Proportion of patients with a sustained virological response (serum HBV DNA <20 IU/mL) at week 48

    Secondary Outcome Measures

    Full Information

    First Posted
    July 28, 2017
    Last Updated
    July 28, 2017
    Sponsor
    Uijeongbu St. Mary Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03236584
    Brief Title
    Tenofovir Monotherapy in Patients With Chronic Hepatitis B Patients Who Had Achieved Complete Viral Suppression on Lamivudine Plus Adefovir
    Official Title
    Investigation of Efficacy of Tenofovir Monotherapy in Comparison With Lamivudine Plus Adefovir in Patients With Chronic Hepatitis B Patients Who Had Achieved Complete Viral Suppression on Lamivudine Plus Adefovir Combination Therapy - Multicenter Randomized Open-label Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 1, 2015 (Actual)
    Primary Completion Date
    March 30, 2018 (Anticipated)
    Study Completion Date
    March 30, 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Uijeongbu St. Mary Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    Little is known about efficacy of switching to tenofovir monotherapy for lam-resistant chronic hepatitis B patients who achieved a complete virological response to lamivudine plus adefovir. This study was to investigate the efficacy of switching to tenofovir monotherapy for lamivudine -resistant chronic hepatitis B patients with undetectable hepatitis B virus DNA while on lamivudine plus adefovir combination therapy

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Proportion of Patients With a Sustained Virological Response (Serum HBV DNA <20 IU/mL) at Week 48

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    76 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    lamivudine adefovir
    Arm Type
    Active Comparator
    Arm Title
    tenofovir
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    lamivudine plus adefovir combination
    Intervention Description
    continuing lamivudine plus adefovir
    Intervention Type
    Drug
    Intervention Name(s)
    Tenofovir Disoproxil Fumarate
    Intervention Description
    switching to tenofovir
    Primary Outcome Measure Information:
    Title
    SVR
    Description
    Proportion of patients with a sustained virological response (serum HBV DNA <20 IU/mL) at week 48
    Time Frame
    48 WEEK

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    19 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: HBsAg (+) for > 6 months age >19 years antiviral resistance to LAM (rtL180M and/or M204V/I) currently receiving LAM plus ADV for more than 12 months HBV DNA levels <20 IU/ml on two consecutive tests of 3-month interval Exclusion Criteria: Cr ≥1.5 mg/dL Evidence of decompensated liver disease Malignant neoplasm Coinfection with HIV, HCV

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Tenofovir Monotherapy in Patients With Chronic Hepatitis B Patients Who Had Achieved Complete Viral Suppression on Lamivudine Plus Adefovir

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