Clinical trial NCT00835068: Post Marketing Observational Study of Reformulated BeneFIX
Official title: Post Marketing Observational Study Of Reformulated BeneFIX
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hemophilia B
Keywords: Hemophilia B
observational
post marketing study
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-02-03
Enrollment: 58
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hemophilia B patients already receiving or starting treatment with reformulated BeneFIX

Brief summary: 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.

Detailed description: No sampling

Eligibility 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).

Primary outcomes:
measure: Number of Participants With Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs) Prior to Safety Amendment
timeFrame: Baseline up to Year 3.5
measure: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) by Relationship After Safety Amendment
timeFrame: Year 3.5 up to 4.75
measure: Number of Participants With Events of Special Interest
timeFrame: Baseline up to Year 4.75
Secondary outcomes:
measure: Number of Bleeding Episodes
timeFrame: Baseline up to Year 4.75
measure: Number of Bleeding Episodes Requiring Treatment by Injection
timeFrame: Baseline up to Year 4.75
measure: Total Consumption of BeneFIX
timeFrame: Baseline up to Year 4.75
measure: Subjective Assessment of Efficacy by Participant
timeFrame: Baseline up to Year 4.75
measure: Dose Per Injection of BeneFIX
timeFrame: Baseline up to Year 4.75
measure: Subjective Assessment of Efficacy by Physician
timeFrame: Baseline up to Year 4.75
measure: Subjective Assessment of Ease of Use by Participant
timeFrame: Baseline up to Year 4.75
Other outcomes:
Locations:
city: Chamberry
country: France
facility: Pfizer Investigational Site
state: Cedex
city: Le Chesnay
country: France
facility: Pfizer Investigational Site
state: Cedex
city: Caen Cedex 9
country: France
facility: Pfizer Investigational Site
city: Clermont Ferrand
country: France
facility: Pfizer Investigational Site
city: Dijon Cedex
country: France
facility: Pfizer Investigational Site
city: leKremlin-Bicetre
country: France
facility: Pfizer Investigational Site
city: Lyon
country: France
facility: Pfizer Investigational Site
city: Marseille Cedex 05
country: France
facility: Pfizer Investigational Site
city: Montmorency
country: France
facility: Pfizer Investigational Site
city: Montpellier Cedex 5
country: France
facility: Pfizer Investigational Site
city: Nantes cedex 1
country: France
facility: Pfizer Investigational Site
city: Paris
country: France
facility: Pfizer Investigational Site
city: Paris
country: France
facility: Pfizer Investigational Site
city: Rouen
country: France
facility: Pfizer Investigational Site
city: Saint Priest en Jarez
country: France
facility: Pfizer Investigational Site
city: Tours
country: France
facility: Pfizer Investigational Site
city: Vandoeuvre Les Nancy Cedex
country: France
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: