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Continue Entecavir Rollover From China

Primary Purpose

Chronic Hepatitis B Virus

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Entecavir
Entecavir
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Hepatitis B Virus

Eligibility Criteria

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

Inclusion Criteria:

  • Subjects who had completed the required dosing period in a previous ETV Phase 2 or 3 study in China (studies AI463012, AI463023, AI463056), and had been assessed by the Investigators as likely to benefit from additional therapy for treatment of their HBV infection
  • ALT ≤ 15 x upper limit of normal
  • Compensated liver disease

Exclusion Criteria:

  • Coinfection with HIV, HCV, or HDV

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Entecavir 0.5

    Entecavir 1.0

    Arm Description

    Outcomes

    Primary Outcome Measures

    The number and percentage of subjects with adverse events, laboratory abnormalities, and discontinuations due to adverse events

    Secondary Outcome Measures

    The change in the mean HBV DNA measured by PCR assay from baseline for each entecavir cohort

    Full Information

    First Posted
    September 8, 2009
    Last Updated
    January 29, 2010
    Sponsor
    Bristol-Myers Squibb
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00975091
    Brief Title
    Continue Entecavir Rollover From China
    Official Title
    A Study of the Safety and Antiviral Activity of Open-Label Entecavir (BMS-200475) in Adults With Chronic Hepatitis B Infection Who Have Completed Dosing in a Previous Phase II/III Study in China
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2009
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2004 (undefined)
    Primary Completion Date
    August 2007 (Actual)
    Study Completion Date
    August 2007 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Bristol-Myers Squibb

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of the study is to determine if treatment with entecavir is safe and well tolerated in patients who completed dosing in a previous entecavir study in China, but are requiring further treatment of their chronic hepatitis B virus infection.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    600 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Entecavir 0.5
    Arm Type
    Active Comparator
    Arm Title
    Entecavir 1.0
    Arm Type
    Active Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    Entecavir
    Other Intervention Name(s)
    Baraclude, BMS-200475
    Intervention Description
    Tablets, Oral, 0.5 mg, once daily, Until ETV is commercially available in China or when Post Study Drug Program is started
    Intervention Type
    Drug
    Intervention Name(s)
    Entecavir
    Other Intervention Name(s)
    Baraclude, BMS-200475
    Intervention Description
    Tablets, Oral, 1.0 mg, once daily, Until ETV is commercially available in China or when Post Study Drug Program is started
    Primary Outcome Measure Information:
    Title
    The number and percentage of subjects with adverse events, laboratory abnormalities, and discontinuations due to adverse events
    Time Frame
    Through 3 years of dosing and up to 48 weeks of off treatment follow up
    Secondary Outcome Measure Information:
    Title
    The change in the mean HBV DNA measured by PCR assay from baseline for each entecavir cohort
    Time Frame
    Through 3 years of dosing

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    16 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Subjects who had completed the required dosing period in a previous ETV Phase 2 or 3 study in China (studies AI463012, AI463023, AI463056), and had been assessed by the Investigators as likely to benefit from additional therapy for treatment of their HBV infection ALT ≤ 15 x upper limit of normal Compensated liver disease Exclusion Criteria: Coinfection with HIV, HCV, or HDV
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Bristol-Myers Squibb
    Organizational Affiliation
    Bristol-Myers Squibb
    Official's Role
    Study Director

    12. IPD Sharing Statement

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