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Study Evaluating BENEFIX in Previously Treated Patients With Hemophilia B

Primary Purpose

Hemophilia B

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Recombinant Factor IX Coagulation
Sponsored by
Wyeth is now a wholly owned subsidiary of Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hemophilia B focused on measuring BENEFIX, Hemophilia B

Eligibility Criteria

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

Inclusion Criteria:

  1. Patients with moderate to severe hemophilia B ( < 5% circulating factor IX activity) having acute hemorrhage or requiring "short-term therapy" for intermittent secondary prophylaxis regimens.
  2. HIV seropositive ( asymptomatic) or seronegative subjects.
  3. No history or detectable inhibitors.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    1

    Arm Description

    Patients will receive Benefix IV according to blood amount

    Outcomes

    Primary Outcome Measures

    The primary variable will be the clinical response of BeneFix* in avoiding stopping or avoiding bleeding.

    Secondary Outcome Measures

    The secondary variables will be hemostasis and blood loss during and after surgery.

    Full Information

    First Posted
    December 21, 2007
    Last Updated
    December 26, 2007
    Sponsor
    Wyeth is now a wholly owned subsidiary of Pfizer
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00581126
    Brief Title
    Study Evaluating BENEFIX in Previously Treated Patients With Hemophilia B
    Official Title
    Evaluation of Efficacy and Safety of Benefix®- Coagulation Factor ix, Recombinant, in Previously Treated Patients With Hemophilia b.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2007
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2001 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    July 2004 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Wyeth is now a wholly owned subsidiary of Pfizer

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    To assess efficacy and safety of BeneFix® for prophylaxis in "Short-term" therapy and on demand therapy for all bleeding episodes of subjects with hemophilia B.
    Detailed Description
    Phase IV, open-label, non comparative, multicenter, previously treated patients (PTP) clinical trial. Patients with severe or moderate hemophilia B with baseline levels of plasma factor IX < 5% activity will participate in this study for both treatment regimens: "on demand" therapy for acute bleeding episodes and therapy for prophylaxis of bleeding episodes ( "Short-term therapy")*. * Short-Term Therapy: Prophylactic therapy given before surgery, including dental procedures, prior to a event that would likely result in bleeding ( sports, exercise, or heavy work), as well as to prevent further bleeds into a target joint). This short-term therapy for intermittent secondary therapy.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hemophilia B
    Keywords
    BENEFIX, Hemophilia B

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    14 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Experimental
    Arm Description
    Patients will receive Benefix IV according to blood amount
    Intervention Type
    Drug
    Intervention Name(s)
    Recombinant Factor IX Coagulation
    Intervention Description
    Benefix IV each 12 hours for 2 a 5 days
    Primary Outcome Measure Information:
    Title
    The primary variable will be the clinical response of BeneFix* in avoiding stopping or avoiding bleeding.
    Time Frame
    9 months
    Secondary Outcome Measure Information:
    Title
    The secondary variables will be hemostasis and blood loss during and after surgery.
    Time Frame
    9 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients with moderate to severe hemophilia B ( < 5% circulating factor IX activity) having acute hemorrhage or requiring "short-term therapy" for intermittent secondary prophylaxis regimens. HIV seropositive ( asymptomatic) or seronegative subjects. No history or detectable inhibitors.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Medical Monitor
    Organizational Affiliation
    Wyeth is now a wholly owned subsidiary of Pfizer
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Study Evaluating BENEFIX in Previously Treated Patients With Hemophilia B

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