Post Marketing Observational Study of Reformulated BeneFIX
2 other identifiers
observational
58
1 country
17
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jan 2009
Longer than P75 for all trials
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2009
CompletedFirst Submitted
Initial submission to the registry
February 2, 2009
CompletedFirst Posted
Study publicly available on registry
February 3, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2013
CompletedResults Posted
Study results publicly available
September 17, 2014
CompletedSeptember 17, 2014
September 1, 2014
4.8 years
February 2, 2009
September 11, 2014
September 11, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Number of Participants With Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs) Prior to Safety Amendment
A treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included SAEs as well as non-serious AEs which occurred prior to safety amendment. Prior to safety amendment, only AEs/SAEs deemed related to BeneFIX as per participating physician were collected.
Baseline up to Year 3.5
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) by Relationship After Safety Amendment
AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. A treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug as per participating physician. AEs included SAEs as well as non-serious AEs which occurred after the safety amendment. After the safety amendment, all AEs/SAEs were collected irrespective of their relationship to BeneFIX.
Year 3.5 up to 4.75
Number of Participants With Events of Special Interest
Events of special interest included allergic reactions, red blood cell (RBC) agglutination phenomena, lack of efficacy/low recovery, thrombotic events and onset of factor IX (FIX) inhibitor. Participants may be represented in more than 1 category.
Baseline up to Year 4.75
Secondary Outcomes (7)
Number of Bleeding Episodes
Baseline up to Year 4.75
Number of Bleeding Episodes Requiring Treatment by Injection
Baseline up to Year 4.75
Total Consumption of BeneFIX
Baseline up to Year 4.75
Subjective Assessment of Efficacy by Participant
Baseline up to Year 4.75
Dose Per Injection of BeneFIX
Baseline up to Year 4.75
- +2 more secondary outcomes
Study Arms (1)
BeneFIX
Interventions
As it is a non interventional study, patient receives his usual treatment (BeneFIX) as determined by the physician
Eligibility Criteria
Hemophilia B patients already receiving or starting treatment with reformulated BeneFIX
You may qualify if:
- Subjects with Hemophilia B already receiving or starting treatment with reformulated BeneFIX.
- Subjects who have dated and signed the informed consent form.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (17)
Pfizer Investigational Site
Chamberry, Cedex, 73011, France
Pfizer Investigational Site
Le Chesnay, Cedex, 78157, France
Pfizer Investigational Site
Caen, 14033, France
Pfizer Investigational Site
Clermont-Ferrand, 63003, France
Pfizer Investigational Site
Dijon, 21070, France
Pfizer Investigational Site
leKremlin-Bicetre, 94275, France
Pfizer Investigational Site
Lyon, 69003, France
Pfizer Investigational Site
Marseille, 13385, France
Pfizer Investigational Site
Montmorency, 95160, France
Pfizer Investigational Site
Montpellier, 34 34295, France
Pfizer Investigational Site
Nantes, 44093, France
Pfizer Investigational Site
Paris, 75014, France
Pfizer Investigational Site
Paris, F-75015, France
Pfizer Investigational Site
Rouen, 76031, France
Pfizer Investigational Site
Saint-Priest-en-Jarez, 42277, France
Pfizer Investigational Site
Tours, 37044, France
Pfizer Investigational Site
Vandœuvre-lès-Nancy, 54511, France
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer, Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 2, 2009
First Posted
February 3, 2009
Study Start
January 1, 2009
Primary Completion
October 1, 2013
Study Completion
October 1, 2013
Last Updated
September 17, 2014
Results First Posted
September 17, 2014
Record last verified: 2014-09