Study Evaluating Pharmacovigilance Of Refacto AF

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00895037
Recruitment Status : Active, not recruiting
First Posted : May 7, 2009
Last Update Posted : August 29, 2017
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment
Hemophilia A Drug: ReFacto AF (Moroctocog alfa)

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

Study Type : Observational
Actual Enrollment : 101 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Refacto Af (Registered) Pharmacovigilance Study
Actual Study Start Date : July 17, 2009
Actual Primary Completion Date : October 30, 2016
Estimated Study Completion Date : October 15, 2017

Group/Cohort Intervention/treatment
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

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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 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
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
Universität Regensburg
Regensburg, Germany, 93042
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

Additional Information:
Responsible Party: Pfizer Identifier: NCT00895037     History of Changes
Other Study ID Numbers: 3082B2-4420
B1831016 ( Other Identifier: Alias Study Number )
First Posted: May 7, 2009    Key Record Dates
Last Update Posted: August 29, 2017
Last Verified: August 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