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Safety and Antiviral Study of ACH-126, 443 (Beta-L-Fd4C) in the Treatment of Adults With Chronic Hepatitis B Infection.

Primary Purpose

Chronic Hepatitis B

Status
Terminated
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
ACH-126, 443 (beta-L-Fd4C)
Sponsored by
Alexion
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Hepatitis B focused on measuring E-antigen positive, treatment naïve chronic HBV infected, lamivudine resistant chronic Hepatitis B, Achillion

Eligibility Criteria

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

Inclusion Criteria: Participants in previous Phase 1 or 2 trials of ACH-126,443 who met entry criteria for previous studies. Adults ? 18 years of age Chronic HBV infection, known to be HbsAg positive ? 6 months Plasma HBV DNA level ? 100,000 copies/mL prior to initiation of ACH-126,443 in an earlier study Plasma HBV DNA level that in the medical judgment of the investigator, warrant's antiviral treatment HIV negative Basic hematologic and chemistry parameters within acceptable limits (defined in protocol) No need for excluded medications Subjects of reproductive capability must either practice abstinence or utilize two approved forms of birth control, one of which must be barrier protection (condom with spermicidal, diaphragm with spermicidal) Exclusion Criteria HIV infection Active Hepatitis C co-infection Concurrent systemic antiviral treatment Treatment for HBV infection with lamivudine (3TC) for longer than three (3) months since participation in previous trial of ACH-126,443 Previous therapy with agents with significant systemic myelosuppressive or cytotoxic potential within 3 months of study start or the expected need for such therapy at study start Alcohol abuse Pregnancy or breast-feeding Inability to tolerate oral medication AST>10.0 times the upper limit of normal ALT>10.0 times the upper limit of normal Any clinical condition or prior therapy that, in the Investigators opinion, would make the subject unsuitable for the study or unable to comply with the dosing requirements Use of investigational drug not approved by Medical Monitor

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    May 17, 2002
    Last Updated
    August 18, 2009
    Sponsor
    Alexion
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00037622
    Brief Title
    Safety and Antiviral Study of ACH-126, 443 (Beta-L-Fd4C) in the Treatment of Adults With Chronic Hepatitis B Infection.
    Official Title
    An Open-Label Treatment Protocol to Provide Continued ACH-126,443 to Subjects of Previous Achillion-Sponsored Phase 1 and 2 Studies in Chronic Hepatitis B Infection
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2009
    Overall Recruitment Status
    Terminated
    Why Stopped
    Safety concerns from other studies.
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    May 2003 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Alexion

    4. Oversight

    5. Study Description

    Brief Summary
    The purpose of this study is to determine the safety and antiviral HBV activity of ACH-126,443 (beta-L-Fd4C) in the treatment of Subjects of Previous Achillion-Sponsored Phase 1 and 2 Studies in Chronic Hepatitis B Infection.
    Detailed Description
    Evaluation of safety and antiviral activity of the 5mg dose of ACH-126,443 for up to three months of treatment in the population described.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Hepatitis B
    Keywords
    E-antigen positive, treatment naïve chronic HBV infected, lamivudine resistant chronic Hepatitis B, Achillion

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    100 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    ACH-126, 443 (beta-L-Fd4C)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Participants in previous Phase 1 or 2 trials of ACH-126,443 who met entry criteria for previous studies. Adults ? 18 years of age Chronic HBV infection, known to be HbsAg positive ? 6 months Plasma HBV DNA level ? 100,000 copies/mL prior to initiation of ACH-126,443 in an earlier study Plasma HBV DNA level that in the medical judgment of the investigator, warrant's antiviral treatment HIV negative Basic hematologic and chemistry parameters within acceptable limits (defined in protocol) No need for excluded medications Subjects of reproductive capability must either practice abstinence or utilize two approved forms of birth control, one of which must be barrier protection (condom with spermicidal, diaphragm with spermicidal) Exclusion Criteria HIV infection Active Hepatitis C co-infection Concurrent systemic antiviral treatment Treatment for HBV infection with lamivudine (3TC) for longer than three (3) months since participation in previous trial of ACH-126,443 Previous therapy with agents with significant systemic myelosuppressive or cytotoxic potential within 3 months of study start or the expected need for such therapy at study start Alcohol abuse Pregnancy or breast-feeding Inability to tolerate oral medication AST>10.0 times the upper limit of normal ALT>10.0 times the upper limit of normal Any clinical condition or prior therapy that, in the Investigators opinion, would make the subject unsuitable for the study or unable to comply with the dosing requirements Use of investigational drug not approved by Medical Monitor

    12. IPD Sharing Statement

    Links:
    URL
    http://www.achillion.com
    Description
    Related Info

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    Safety and Antiviral Study of ACH-126, 443 (Beta-L-Fd4C) in the Treatment of Adults With Chronic Hepatitis B Infection.

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