Post Marketing Observational Study Of Reformulated BeneFIX
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Hemophilia B
- Sponsor
- Pfizer
- Enrollment
- 58
- Locations
- 1
- Primary Endpoint
- Number of Participants With Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs) Prior to Safety Amendment
- Status
- Completed
- Last Updated
- 11 years ago
Overview
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
Investigators
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).
Outcomes
Primary Outcomes
Number of Participants With Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs) Prior to Safety Amendment
Time Frame: Baseline up to Year 3.5
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.
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) by Relationship After Safety Amendment
Time Frame: Year 3.5 up to 4.75
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.
Number of Participants With Events of Special Interest
Time Frame: Baseline up to Year 4.75
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.
Secondary Outcomes
- 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)
- Subjective Assessment of Efficacy by Physician(Baseline up to Year 4.75)
- Subjective Assessment of Ease of Use by Participant(Baseline up to Year 4.75)