Study Evaluating BENEFIX in Previously Treated Patients With Hemophilia B - Full Text View

Sponsor:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00581126

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 IV

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Efficacy Study
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:

Genetics Home Reference related topics: hemophilia Help Me Understand Genetics

Drug Information available for: Factor IX

U.S. FDA Resources

Further study details as provided by Wyeth:

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
1: Experimental 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:

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.

Contacts and Locations

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

Sponsors and Collaborators

Wyeth

Investigators

Study Director:

Medical Monitor

Wyeth

More Information

No publications provided

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

Keywords provided by Wyeth:

BENEFIX
Hemophilia B

Additional relevant MeSH terms:

Hemophilia B
Hemorrhagic Disorders
Blood Coagulation Disorders, Inherited
Genetic Diseases, Inborn
Coagulation Protein Disorders

Hematologic Diseases
Blood Coagulation Disorders
Hemophilia A
Genetic Diseases, X-Linked

ClinicalTrials.gov processed this record on February 08, 2010