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Trial of Telbivudine Combination Therapy vs. Continued Adefovir Monotherapy

Primary Purpose

Chronic Hepatitis B

Status
Withdrawn
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Telbivudine
Adefovir
Tenofovir
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Hepatitis B

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All Sexes

Inclusion Criteria:

  • Documented compensated chronic hepatitis B defined by clinical history compatible with chronic hepatitis B
  • Patient is currently receiving Hepsera (adefovir dipivoxil) and has received treatment continuously for a minimum of 5 months prior to screening.

Other inclusion criteria may apply.

Exclusion Criteria:

  • Patient is pregnant or breastfeeding
  • Patient is co-infected with hepatitis C, hepatitis D or HIV
  • Patient previously received nucleoside(tide) therapy other than adefovir
  • Patient previously received an interferon-based treatment or an investigational agent for hepatitis B in the preceding 12 months

Other exclusion criteria may apply.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Experimental

    Arm Label

    1

    2

    3

    Arm Description

    Study cancelled: Withdrawn before enrollment of any participants

    Study cancelled: Withdrawn before enrollment of any participants

    Study cancelled: Withdrawn before enrollment of any participants

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    December 7, 2006
    Last Updated
    March 5, 2015
    Sponsor
    Novartis Pharmaceuticals
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00409019
    Brief Title
    Trial of Telbivudine Combination Therapy vs. Continued Adefovir Monotherapy
    Official Title
    A Prospective, Randomized, Trial to Investigate the Effect of Continued Adefovir Versus Combination Regimens of Telbivudine Plus Adefovir, and Telbivudine Plus Tenofovir in Patients With Chronic Hepatitis B and Suboptimal Viral Suppression (PROACTIV Study)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2015
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Study cancelled: Withdrawn before enrollment of any participants
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    March 2011 (Actual)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Novartis Pharmaceuticals

    4. Oversight

    5. Study Description

    Brief Summary
    The purpose of this study is to find out if taking a combination of telbivudine and adefovir or tenofovir and telbivudine can lower the amount of Hepatitis B virus in patients that have been taking adefovir alone for at least 5 months and have had less than optimal responses. The safety of taking telbivudine and adefovir together or tenofovir and telbivudine together will also be studied.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Hepatitis B

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Experimental
    Arm Description
    Study cancelled: Withdrawn before enrollment of any participants
    Arm Title
    2
    Arm Type
    Experimental
    Arm Description
    Study cancelled: Withdrawn before enrollment of any participants
    Arm Title
    3
    Arm Type
    Experimental
    Arm Description
    Study cancelled: Withdrawn before enrollment of any participants
    Intervention Type
    Drug
    Intervention Name(s)
    Telbivudine
    Intervention Description
    Study cancelled: Withdrawn before enrollment of any participants
    Intervention Type
    Drug
    Intervention Name(s)
    Adefovir
    Intervention Type
    Drug
    Intervention Name(s)
    Tenofovir

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Eligibility Criteria
    Inclusion Criteria: Documented compensated chronic hepatitis B defined by clinical history compatible with chronic hepatitis B Patient is currently receiving Hepsera (adefovir dipivoxil) and has received treatment continuously for a minimum of 5 months prior to screening. Other inclusion criteria may apply. Exclusion Criteria: Patient is pregnant or breastfeeding Patient is co-infected with hepatitis C, hepatitis D or HIV Patient previously received nucleoside(tide) therapy other than adefovir Patient previously received an interferon-based treatment or an investigational agent for hepatitis B in the preceding 12 months Other exclusion criteria may apply.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Novartis Pharmaceuticals
    Organizational Affiliation
    Novartis Pharmaceuticals
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Trial of Telbivudine Combination Therapy vs. Continued Adefovir Monotherapy

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