Study Evaluating BENEFIX in Previously Treated Patients With Hemophilia B

Hemophilia B Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00581126
• Other study ID #: 3090A-100932
• Status: Completed
• Phase: Phase 4
• First received: December 21, 2007
• Last updated: December 26, 2007
• Start date: December 2001
• Est. completion date: July 2004

Study information

• Verified date: December 2007
• Source: Wyeth is now a wholly owned subsidiary of Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: July 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hemophilia A
• Hemophilia B

Intervention

Drug:
• Recombinant Factor IX Coagulation
Benefix IV each 12 hours for 2 a 5 days

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary variable will be the clinical response of BeneFix* in avoiding stopping or avoiding bleeding.		9 months	No
Secondary	The secondary variables will be hemostasis and blood loss during and after surgery.		9 months	No