Pharmacovigilance Evaluation Of Refacto Af (Registered) In Germany And Austria
Overview
- Phase
- Not Applicable
- Intervention
- ReFacto AF (Moroctocog alfa)
- Conditions
- Hemophilia A
- Sponsor
- Pfizer
- Enrollment
- 101
- Locations
- 24
- Primary Endpoint
- Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
The purpose of this observational study is to describe the incidence of adverse events among patients treated with Refacto AF in usual health care settings in Germany and Austria.
Detailed Description
Non-interventional study: subjects to be selected according to the usual clinical practice of their physician
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients with hemophilia A of any severity already receiving or starting treatment with ReFacto AF.
Exclusion Criteria
- •Patients with Hemophilia A treated with a product other than Refacto AF.
Arms & Interventions
1
Patients treated with Refacto AF
Intervention: ReFacto AF (Moroctocog alfa)
Outcomes
Primary Outcomes
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame: Baseline until last visit (up to 87 months)
An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. 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 or incapacity; cancer; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to last visit (up to 87 months) that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious adverse events.
Number of Participants With Factor VIII (FVIII) Inhibitor Development as Measured by the Nijmegen-Modified Bethesda Assay
Time Frame: Baseline until last visit (up to 87 months)
FVIII inhibitor development was defined as measured inhibitor titer of greater than (\>) 0.6 Bethesda Units (BU) using the Nijmegen-modified Bethesda assay.
Number of Participants With Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame: Baseline until last visit (up to 87 months)
Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. 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; cancer; congenital anomaly. AEs included both serious and non-serious adverse events. Relatedness of AEs with Refacto AF was assessed by the investigator.
Mean Total Number of Bleeding Episodes in Participants
Time Frame: Baseline until last visit (up to 87 months)
Participants documented all bleeding episodes in a diary during the study.
Secondary Outcomes
- Investigator Assessment of Treatment Satisfaction of Participants(End of study visit (any time up to 87 months))
- Mean Total Number of Bleeding Episodes Per Year in Participants(Baseline until last visit (up to 87 months))
- Participant Assessment of Satisfaction With Treatment Handling(End of study visit (any time up to 87 months))
- Number of Participants With Change From Baseline Status in Days Missed From School or Work(Baseline until last visit (up to 87 months))