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Completed

NCT Number: NCT00581126

Study Evaluating BENEFIX 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.

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Key information

Conditions

Hemophilia B Blood Coagulation Disorders Blood Coagulation Disorders, Inherited Coagulation Protein Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Genetic Diseases, X-Linked Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders

Age range

6 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Recombinant Factor IX Coagulation

Drug

Benefix IV each 12 hours for 2 a 5 days

Primary outcomes

  1. The primary variable will be the clinical response of BeneFix* in avoiding stopping or avoiding bleeding.

    Time frame: 9 months

Secondary outcomes

  1. The secondary variables will be hemostasis and blood loss during and after surgery.

    Time frame: 9 months

Sponsors and collaborators

Lead sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Industry

Registry information

Official study title

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

Important dates

Study start
2001
Study completion
2004
First posted
Dec 27, 2007
Registry last updated
Dec 27, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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