Study Evaluating BENEFIX in Previously Treated Patients With Hemophilia B

Evaluation of Efficacy and Safety of Benefix®- Coagulation Factor ix, Recombinant, in Previously Treated Patients With Hemophilia b.

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.

Study Overview

• Status: Completed
• Conditions: Hemophilia B
• Intervention / Treatment: Drug: Recombinant Factor IX Coagulation

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.

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; Patients will receive Benefix IV according to blood amount	Drug: Recombinant Factor IX Coagulation; Benefix IV each 12 hours for 2 a 5 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The primary variable will be the clinical response of BeneFix* in avoiding stopping or avoiding bleeding.	9 months

Secondary Outcome Measures

Outcome Measure	Time Frame
The secondary variables will be hemostasis and blood loss during and after surgery.	9 months

Collaborators and Investigators

• Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Study record dates

Study Major Dates

• Study Start: December 1, 2001
• Study Completion (Actual): July 1, 2004

Study Registration Dates

• First Submitted: December 21, 2007
• First Submitted That Met QC Criteria: December 26, 2007
• First Posted (Estimate): December 27, 2007

Study Record Updates

• Last Update Posted (Estimate): December 27, 2007
• Last Update Submitted That Met QC Criteria: December 26, 2007
• Last Verified: December 1, 2007

More Information

Terms related to this study

• Keywords: Hemophilia B; BENEFIX
• Additional Relevant MeSH Terms: Hematologic Diseases; Blood Coagulation Disorders, Inherited; Coagulation Protein Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Genetic Diseases, X-Linked; Blood Coagulation Disorders; Hemophilia A; Hemophilia B
• Other Study ID Numbers: 3090A-100932