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Study Evaluating Pharmacovigilance Of Refacto AF

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00895037
First Posted: May 7, 2009
Last Update Posted: October 12, 2017
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.
Information provided by (Responsible Party):
Pfizer
  Purpose
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 ]

Enrollment: 101
Actual Study Start Date: July 17, 2009
Estimated Study Completion Date: October 15, 2017
Primary Completion Date: October 30, 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
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
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
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.
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00895037


Locations
Austria
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
Germany
Sonnengesundheitszentrum
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
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00895037     History of Changes
Other Study ID Numbers: 3082B2-4420
B1831016 ( Other Identifier: Alias Study Number )
First Submitted: May 1, 2009
First Posted: May 7, 2009
Last Update Posted: October 12, 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
Coagulants