Study Evaluating Pharmacovigilance Of Refacto AF
- Conditions
- Hemophilia A
- Interventions
- Drug: ReFacto AF (Moroctocog alfa)
- Registration Number
- NCT00895037
- Lead Sponsor
- Pfizer
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 101
- Patients with hemophilia A of any severity already receiving or starting treatment with ReFacto AF.
- Patients with Hemophilia A treated with a product other than Refacto AF.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description 1 ReFacto AF (Moroctocog alfa) Patients treated with Refacto AF
- Primary Outcome Measures
Name Time Method Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) 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 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) 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 Baseline until last visit (up to 87 months) Participants documented all bleeding episodes in a diary during the study.
- Secondary Outcome Measures
Name Time Method Investigator Assessment of Treatment Satisfaction of Participants End of study visit (any time up to 87 months) Investigator assessed the treatment satisfaction of participants and categorized as very satisfied, satisfied, unsatisfied, or very unsatisfied.
Mean Total Number of Bleeding Episodes Per Year in Participants Baseline until last visit (up to 87 months) Participants documented all bleeding episodes in a diary during the study. Mean total number of bleeding episodes per year was calculated as: mean total number of bleeding episodes divided by duration of observation period (in years) for bleeding documentation.
Participant Assessment of Satisfaction With Treatment Handling End of study visit (any time up to 87 months) Participants evaluated their satisfaction with handing (administration) of Refacto AF and rated it in 4 categories as: very satisfied, satisfied, unsatisfied and very unsatisfied.
Number of Participants With Change From Baseline Status in Days Missed From School or Work Baseline until last visit (up to 87 months) Change from baseline status in days missed from school or work was categorized in 3 categories: Improvement, unchanged and worsening. Improvement defined as a decrease in number of days missed by participants from school/work as compared to baseline; worsening was defined as an increase in number of days missed by participants from school/work as compared to baseline; unchanged was defined as no change in number of days missed by participants from school/work as compared to baseline. In this outcome measure, number of participants with change from baseline status (as improved, worsen, unchanged) in days missed from school/work were reported.
Trial Locations
- Locations (24)
Universitaetsklinikum Duesseldorf
🇩🇪Duesseldorf, Germany
Stiftung Deutsche Klinik fur Diagnostik GmbH
🇩🇪Wiesbaden, Germany
Klinikum Bremen Mitte
🇩🇪Bremen, Germany
Hämophilie-Zentrum Rhein Main GmbH
🇩🇪Mörfelden-Walldorf, Germany
Universität Regensburg
🇩🇪Regensburg, Germany
Asklepios Fachklinikum Stadtroda GmbH
🇩🇪Stadtroda, Germany
Vivantes Klinikum im Friedrichshain
🇩🇪Berlin, Germany
Allgemeines Krankenhaus Linz, Kinderklinik
🇦🇹Linz, Austria
Institut for Thrombophilia and Hemastaseologie
🇩🇪Muenster, Germany
Universitaetsklinik fuer Kinder- und Jugendmedizin
🇩🇪Tuebingen, Germany
Praxis Dr. Autenrieth
🇩🇪Metzingen, Germany
Stauferklinikum Schwaebisch Gmuend
🇩🇪Mutlangen, Germany
Praxis zur Diagnostik und Therapie Von Blutgerinnungstoerungen
🇩🇪Frankfurt a. M., Germany
Praxis fur Kinder- und Jugendmedizin
🇩🇪Grunwald, Germany
Klinikum Stuttgart
🇩🇪Stuttgart, Germany
LKH - Univ. Klinikum Graz,Abt. fur Hamatologie
🇦🇹Graz, Austria
Universitaetsklinikum Duesseldorf, Klinik f. Kinder-Onkologie, Haematologie u. Klinische Immunologie
🇩🇪Duesseldorf, Germany
Universitaetsklinik fuer Innere Medizin 1
🇦🇹Wien, Austria
Sonnengesundheitszentrum
🇩🇪München, Bayern, Germany
Werlhof-Institut für Haemostaseologie GmbH
🇩🇪Hannover, Niedersachsen, Germany
Donaustrasse 78
🇩🇪Memmingen, Germany
CRC Coagulation Research Centre GmbH
🇩🇪Duisburg, Germany
SRH Kurpfalzkrankenhaus Heidelberg
🇩🇪Heidelberg, Germany
Medizinische Hochschule Hannover
🇩🇪Hannover, Germany