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Continued Access Study of Adefovir Dipivoxil (ADV) for Patients w/Chronic HBV Infection.

Primary Purpose

Hepatitis B

Status
Terminated
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Hepsera
Sponsored by
Gilead Sciences
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis B focused on measuring Chronic Hepatitis B

Eligibility Criteria

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

Inclusion Criteria: Must have completed one of the following Gilead-sponsored studies as indicated: GS-96-412, GS-98-437, GS-98-438, GS-00-461 and GS-00-481. If the patient has participated in another Gilead-sponsored study, the CRO or Sponsor's Medical Monitor will evaluate for participation in this study on a case by case basis. Exclusion Criteria: Any serious or active medical or psychiatric illness that would interfere with patient treatment, assessment or compliance with the protocol or dosing requirements. Currently receiving nephrotoxic drugs such as aminoglycosides (e.g. amikacin, gentamicin, kanamycin, neomycin, netilmicin, streptomycin, tobramycin), amphotericin B, vancomycin, cidofovir, foscarnet, cisplatin, or pentamidine OR competitors of renal excretion such as probenecid and sulfinpyrazone. These agents must be discontinued at least 7 days prior to starting treatment with adefovir dipivoxil. Currently receiving investigational agents with activity against hepatitis B virus. Hypersensitivity to any of the components of the drug product. Pregnant or lactating females. Inability to comply with study requirements. Experienced a treatment limiting toxicity of adefovir dipivoxil that has not yet resolved or resulted in permanent discontinuation of adefovir dipivoxil in the previous study.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    To provide adefovir dipivoxil (ADV) 10 mg once daily to patients with chronic hepatitis B virus (HBV) infection who have completed a Gilead-sponsored study and require continued access to ADV.

    Secondary Outcome Measures

    To evaluate the safety of chronic therapy with ADV 10 mg.

    Full Information

    First Posted
    September 7, 2005
    Last Updated
    March 7, 2007
    Sponsor
    Gilead Sciences
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00158704
    Brief Title
    Continued Access Study of Adefovir Dipivoxil (ADV) for Patients w/Chronic HBV Infection.
    Official Title
    An Open-Label, Continued Access Study of Adefovir Dipivoxil for Patients With Chronic HBV Infection Who Have Completed a Gilead-Sponsored Study of Adefovir Dipivoxil.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2006
    Overall Recruitment Status
    Terminated
    Why Stopped
    The study stopped due to marketing approval by the FDA.
    Study Start Date
    January 2002 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    January 2005 (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Gilead Sciences

    4. Oversight

    5. Study Description

    Brief Summary
    Provide adefovir dipivoxil (Hepsera) 10 mg once daily to patients with chronic hepatitis B virus (HBV) infection who have completed a Gilead-sponsored study of adefovir dipivoxil and require continued access to adefovir dipivoxil.
    Detailed Description
    The objective of this study is to provide adefovir dipivoxil 10 mg once daily to patients with chronic hepatitis B virus(HBV) infection who have completed a Gilead-sponsored study of adefovir dipivoxil and require continued access to adefovir dipivoxil. The secondary objective of this study is to evaluate the safety of chronic therapy with adefovir dipivoxil 10 mg.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    400 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Hepsera
    Primary Outcome Measure Information:
    Title
    To provide adefovir dipivoxil (ADV) 10 mg once daily to patients with chronic hepatitis B virus (HBV) infection who have completed a Gilead-sponsored study and require continued access to ADV.
    Secondary Outcome Measure Information:
    Title
    To evaluate the safety of chronic therapy with ADV 10 mg.

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Must have completed one of the following Gilead-sponsored studies as indicated: GS-96-412, GS-98-437, GS-98-438, GS-00-461 and GS-00-481. If the patient has participated in another Gilead-sponsored study, the CRO or Sponsor's Medical Monitor will evaluate for participation in this study on a case by case basis. Exclusion Criteria: Any serious or active medical or psychiatric illness that would interfere with patient treatment, assessment or compliance with the protocol or dosing requirements. Currently receiving nephrotoxic drugs such as aminoglycosides (e.g. amikacin, gentamicin, kanamycin, neomycin, netilmicin, streptomycin, tobramycin), amphotericin B, vancomycin, cidofovir, foscarnet, cisplatin, or pentamidine OR competitors of renal excretion such as probenecid and sulfinpyrazone. These agents must be discontinued at least 7 days prior to starting treatment with adefovir dipivoxil. Currently receiving investigational agents with activity against hepatitis B virus. Hypersensitivity to any of the components of the drug product. Pregnant or lactating females. Inability to comply with study requirements. Experienced a treatment limiting toxicity of adefovir dipivoxil that has not yet resolved or resulted in permanent discontinuation of adefovir dipivoxil in the previous study.

    12. IPD Sharing Statement

    Links:
    URL
    http://www.Gilead.com
    Description
    Website for Gilead

    Learn more about this trial

    Continued Access Study of Adefovir Dipivoxil (ADV) for Patients w/Chronic HBV Infection.

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