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
About this trial
This is an interventional treatment trial for Hemophilia B focused on measuring BENEFIX, Hemophilia B
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.
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
NCT ID
NCT00581126
First Posted
December 21, 2007
Last Updated
December 26, 2007
Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
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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