Post Marketing Observational Study of Reformulated BeneFIX

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00835068
First received: February 2, 2009
Last updated: December 12, 2013
Last verified: December 2013
  Purpose

The primary objective of this observational study is to collect safety data on reformulated BeneFIX as prescribed in routine clinical practice conditions in France. The secondary objectives are to collect data on the clinical course of individuals treated with reformulated BeneFIX and on the ease of reformulated BeneFIX.


Condition Intervention
Hemophilia B
Other: No intervention

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Post Marketing Observational Study Of Reformulated BeneFIX

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Safety as measured by recording at each visit, any adverse effect for which the participating physician considers that a causal relationship with reformulated BeneFIX is possible. [ Time Frame: Up to 5 years ] [ Designated as safety issue: Yes ]
  • Events of special interest: inhibitor, allergic reactions, red blood cell agglutination, inefficacy/low recovery, thrombotic events [ Time Frame: Up to 5 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Number of bleeding episodes [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
  • Number of of injections [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
  • Consumption of FIX during the observational period [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
  • Subjective assessment of efficacy by the patient [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
  • Dose to stop bleeding [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
  • Subjective assessment of efficacy by the physician [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]

Enrollment: 58
Study Start Date: January 2009
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
BeneFIX Other: No intervention
As it is a non interventional study, patient receives his usual treatment (BeneFIX) as determined by the physician

Detailed Description:

No sampling

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Hemophilia B patients already receiving or starting treatment with reformulated BeneFIX

Criteria

Inclusion Criteria:

  • Subjects with Hemophilia B already receiving or starting treatment with reformulated BeneFIX.
  • Subjects who have dated and signed the informed consent form.

Exclusion Criteria:

  • Ongoing treatment of Hemophilia B by a product other than reformulated BeneFIX.
  • Participation in the European prospective registry of patients with Hemophilia B treated with BeneFIX (Wyeth protocol 3090A-101039).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00835068

Locations
France
Pfizer Investigational Site
Chamberry, Cedex, France, 73011
Pfizer Investigational Site
Le Chesnay, Cedex, France, 78157
Pfizer Investigational Site
Caen Cedex 9, France, 14033
Pfizer Investigational Site
Clermont Ferrand, France, 63003
Pfizer Investigational Site
Dijon Cedex, France, 21070
Pfizer Investigational Site
leKremlin-Bicetre, France, 94275
Pfizer Investigational Site
Lyon, France, 69003
Pfizer Investigational Site
Marseille Cedex 05, France, 13385
Pfizer Investigational Site
Montmorency, France, 95160
Pfizer Investigational Site
Montpellier Cedex 5, France, 34 34295
Pfizer Investigational Site
Nantes cedex 1, France, 44093
Pfizer Investigational Site
Paris, France, F-75015
Pfizer Investigational Site
Paris, France, 75014
Pfizer Investigational Site
Rouen, France, 76031
Pfizer Investigational Site
Saint Priest en Jarez, France, 42277
Pfizer Investigational Site
Tours, France, 37044
Pfizer Investigational Site
Vandoeuvre Les Nancy Cedex, France, 54511
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00835068     History of Changes
Other Study ID Numbers: 3090X1-4409, B1821007
Study First Received: February 2, 2009
Last Updated: December 12, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Hemophilia B
observational
post marketing study

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 July 24, 2014