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Study Evaluating BENEFIX in Previously Treated Patients With Hemophilia B

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00581126
First received: December 21, 2007
Last updated: December 26, 2007
Last verified: December 2007
History of Changes
  Purpose

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.


Condition Intervention Phase
Hemophilia B
 Drug: Recombinant Factor IX Coagulation
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of Efficacy and Safety of Benefix®- Coagulation Factor ix, Recombinant, in Previously Treated Patients With Hemophilia b.

Resource links provided by NLM:

Drug Information available for: Factor IX
U.S. FDA Resources

Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Primary Outcome Measures:
  • The primary variable will be the clinical response of BeneFix* in avoiding stopping or avoiding bleeding. [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The secondary variables will be hemostasis and blood loss during and after surgery. [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Enrollment: 14
Study Start Date: December 2001
Study Completion Date: July 2004
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   6 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00581126

Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
  More Information

No publications provided

Responsible Party: Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
ClinicalTrials.gov Identifier: NCT00581126     History of Changes
Other Study ID Numbers: 3090A-100932
Study First Received: December 21, 2007
Last Updated: December 26, 2007
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
BENEFIX
Hemophilia B

Additional relevant MeSH terms:
Hemophilia B
Hemophilia A
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
 Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn
Genetic Diseases, X-Linked

ClinicalTrials.gov processed this record on May 16, 2013