Clinical trial NCT00895037: Study Evaluating Pharmacovigilance Of Refacto AF
Official title: Pharmacovigilance Evaluation Of Refacto Af (Registered) In Germany And Austria
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hemophilia A
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-05-07
Enrollment: 101
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: Patients with hemophilia A

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

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.

Primary outcomes:
measure: Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Baseline until last visit (up to 87 months)
measure: Number of Participants With Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Baseline until last visit (up to 87 months)
measure: Number of Participants With Factor VIII (FVIII) Inhibitor Development as Measured by the Nijmegen-Modified Bethesda Assay
timeFrame: Baseline until last visit (up to 87 months)
measure: Mean Total Number of Bleeding Episodes in Participants
timeFrame: Baseline until last visit (up to 87 months)
Secondary outcomes:
measure: Mean Total Number of Bleeding Episodes Per Year in Participants
timeFrame: Baseline until last visit (up to 87 months)
measure: Number of Participants With Change From Baseline Status in Days Missed From School or Work
timeFrame: Baseline until last visit (up to 87 months)
measure: Participant Assessment of Satisfaction With Treatment Handling
timeFrame: End of study visit (any time up to 87 months)
measure: Investigator Assessment of Treatment Satisfaction of Participants
timeFrame: End of study visit (any time up to 87 months)
Other outcomes:
Locations:
city: Graz
country: Austria
facility: LKH - Univ. Klinikum Graz,Abt. fur Hamatologie
city: Linz
country: Austria
facility: Allgemeines Krankenhaus Linz, Kinderklinik
city: Wien
country: Austria
facility: Universitaetsklinik fuer Innere Medizin 1
city: München
country: Germany
facility: Sonnengesundheitszentrum
state: Bayern
city: Hannover
country: Germany
facility: Werlhof-Institut für Haemostaseologie GmbH
state: Niedersachsen
city: Berlin
country: Germany
facility: Vivantes Klinikum im Friedrichshain
city: Bremen
country: Germany
facility: Klinikum Bremen Mitte
city: Duesseldorf
country: Germany
facility: Universitaetsklinikum Duesseldorf, Klinik f. Kinder-Onkologie, Haematologie u. Klinische Immunologie
city: Duesseldorf
country: Germany
facility: Universitaetsklinikum Duesseldorf
city: Duisburg
country: Germany
facility: CRC Coagulation Research Centre GmbH
city: Frankfurt a. M.
country: Germany
facility: Praxis zur Diagnostik und Therapie Von Blutgerinnungstoerungen
city: Grunwald
country: Germany
facility: Praxis fur Kinder- und Jugendmedizin
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
city: Heidelberg
country: Germany
facility: SRH Kurpfalzkrankenhaus Heidelberg
city: Memmingen
country: Germany
facility: Donaustrasse 78
city: Metzingen
country: Germany
facility: Praxis Dr. Autenrieth
city: Muenster
country: Germany
facility: Institut for Thrombophilia and Hemastaseologie
city: Mutlangen
country: Germany
facility: Stauferklinikum Schwaebisch Gmuend
city: Mörfelden-Walldorf
country: Germany
facility: Hämophilie-Zentrum Rhein Main GmbH
city: Regensburg
country: Germany
facility: Universität Regensburg
city: Stadtroda
country: Germany
facility: Asklepios Fachklinikum Stadtroda GmbH
city: Stuttgart
country: Germany
facility: Klinikum Stuttgart
city: Tuebingen
country: Germany
facility: Universitaetsklinik fuer Kinder- und Jugendmedizin
city: Wiesbaden
country: Germany
facility: Stiftung Deutsche Klinik fur Diagnostik GmbH
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: