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Phase I/II Study of Monoclonal Factor IX Concentrate for Factor IX Deficiency

Primary Purpose

Hemophilia B, Factor IX Deficiency

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
monoclonal factor IX replacement therapy
Sponsored by
National Center for Research Resources (NCRR)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hemophilia B focused on measuring hematologic disorders, rare disease

Eligibility Criteria

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

PROTOCOL ENTRY CRITERIA: Patients with factor IX deficiency.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    February 24, 2000
    Last Updated
    June 23, 2005
    Sponsor
    National Center for Research Resources (NCRR)
    Collaborators
    University of North Carolina
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00004801
    Brief Title
    Phase I/II Study of Monoclonal Factor IX Concentrate for Factor IX Deficiency
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 1998
    Overall Recruitment Status
    Completed
    Study Start Date
    March 1992 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    National Center for Research Resources (NCRR)
    Collaborators
    University of North Carolina

    4. Oversight

    5. Study Description

    Brief Summary
    OBJECTIVES: Assess the safety and long-term efficacy of monoclonal factor IX concentrate in patients with factor IX deficiency.
    Detailed Description
    PROTOCOL OUTLINE: Patients receive monoclonal factor IX replacement therapy as inpatients. Patients with a satisfactory response receive further therapy as needed for bleeding for up to 36 months at home.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hemophilia B, Factor IX Deficiency
    Keywords
    hematologic disorders, rare disease

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1, Phase 2
    Enrollment
    3 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    monoclonal factor IX replacement therapy

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    12 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    PROTOCOL ENTRY CRITERIA: Patients with factor IX deficiency.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Gilbert C. White
    Organizational Affiliation
    University of North Carolina
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Learn more about this trial

    Phase I/II Study of Monoclonal Factor IX Concentrate for Factor IX Deficiency

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