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Study Evaluating Pharmacovigilance Of Refacto AF

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Pfizer Identifier:
First received: May 1, 2009
Last updated: February 15, 2017
Last verified: February 2017
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.

Condition Intervention
Hemophilia A
Drug: ReFacto AF (Moroctocog alfa)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Refacto Af (Registered) Pharmacovigilance Study

Resource links provided by NLM:

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Reporting of adverse events [ Time Frame: 36 months ]

Secondary Outcome Measures:
  • Efficacy in controlling bleeding [ Time Frame: 36 months ]

Estimated Enrollment: 140
Study Start Date: July 2009
Estimated Study Completion Date: October 2017
Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Patients treated with Refacto AF
Drug: ReFacto AF (Moroctocog alfa)
Patients will be treated with intravenous infusion of ReFacto AF per dosing and frequency as prescribed by the subjects' treating physician. ReFacto AF® will be prescribed in the context of routine clinical practice in Germany and Austria, respectively

Detailed Description:
Non-interventional study: subjects to be selected according to the usual clinical practice of their physician

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with hemophilia A

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00895037

LKH - Univ. Klinikum Graz,Abt. fur Hamatologie
Graz, Austria, 8036
Allgemeines Krankenhaus Linz, Kinderklinik
Linz, Austria, 4020
Universitaetsklinik fuer Innere Medizin 1
Wien, Austria, 1090
München, Bayern, Germany, 80336
Werlhof-Institut für Haemostaseologie GmbH
Hannover, Niedersachsen, Germany, 30159
Vivantes Klinikum im Friedrichshain
Berlin, Germany, 10249
Klinikum Bremen Mitte
Bremen, Germany, 28205
Universitaetsklinikum Duesseldorf, Klinik f. Kinder-Onkologie, Haematologie u. Klinische Immunologie
Duesseldorf, Germany, 40225
Universitaetsklinikum Duesseldorf
Duesseldorf, Germany, 40225
CRC Coagulation Research Centre GmbH
Duisburg, Germany, 47051
Praxis Dr. med. Funffinger, Arzt fur Allgemeinmedizin
Eislingen, Germany, 73054
Praxis zur Diagnostik und Therapie Von Blutgerinnungstoerungen
Frankfurt a. M., Germany, 60596
Praxis fur Kinder- und Jugendmedizin
Grunwald, Germany, 82031
Medizinische Hochschule Hannover
Hannover, Germany, 30625
SRH Kurpfalzkrankenhaus Heidelberg
Heidelberg, Germany, 69123
Labor Dr. Reising-Ackermann und Partner
Leipzig, Germany, 04289
Donaustrasse 78
Memmingen, Germany, 87700
Praxis Dr. Autenrieth
Metzingen, Germany, 72555
Institut for Thrombophilia and Hemastaseologie
Muenster, Germany, 48143
Stauferklinikum Schwaebisch Gmuend
Mutlangen, Germany, 73557
Hämophilie-Zentrum Rhein Main GmbH
Mörfelden-Walldorf, Germany, 64546
Asklepios Fachklinikum Stadtroda GmbH
Stadtroda, Germany, 07646
Klinikum Stuttgart
Stuttgart, Germany, 70176
Universitaetsklinik fuer Kinder- und Jugendmedizin
Tuebingen, Germany, 72076
Stiftung Deutsche Klinik fur Diagnostik GmbH
Wiesbaden, Germany, 65191
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Pfizer Identifier: NCT00895037     History of Changes
Other Study ID Numbers: 3082B2-4420
B1831016 ( Other Identifier: Alias Study Number )
Study First Received: May 1, 2009
Last Updated: February 15, 2017

Additional relevant MeSH terms:
Hemophilia A
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn
Factor VIII
Coagulants processed this record on April 26, 2017