Study Evaluating Pharmacovigilance Of Refacto AF

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2015 by Pfizer
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00895037
First received: May 1, 2009
Last updated: May 20, 2015
Last verified: May 2015
  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 Phase
Hemophilia A
Drug: ReFacto AF (Moroctocog alfa)
Phase 4

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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Efficacy in controlling bleeding [ Time Frame: 36 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 140
Study Start Date: July 2009
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: April 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

Ages Eligible for Study:   999 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00895037

Contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021

Locations
Austria
LKH - Univ. Klinikum Graz,Abt. fur Hamatologie Recruiting
Graz, Austria, 8036
Allgemeines Krankenhaus Linz, Kinderklinik Recruiting
Linz, Austria, 4020
Universitaetsklinik fuer Innere Medizin 1 Recruiting
Wien, Austria, 1090
Germany
Sonnengesundheitszentrum Recruiting
München, Bayern, Germany, 80336
Institut fur Thrombophilia and Hemastaseologie Loerstrasse Recruiting
Munster, NRW, Germany, 48143
Vivantes Klinikum im Friedrichshain Recruiting
Berlin, Germany, 10249
Klinikum Bremen Mitte Recruiting
Bremen, Germany, 28205
Universitaetsklinikum Duesseldorf Recruiting
Duesseldorf, Germany, 40225
Universitaetsklinikum Duesseldorf, Klinik f. Kinder-Onkologie, Haematologie u. Klinische Immunologie Recruiting
Duesseldorf, Germany, 40225
CRC Coagulation Research Centre GmbH Recruiting
Duisburg, Germany, 47051
Praxis Dr. med. Funffinger, Arzt fur Allgemeinmedizin Not yet recruiting
Eislingen, Germany, 73054
Praxis fuer Blutgerinnungstoerungen Recruiting
Frankfurt a. M., Germany, 60596
Praxis fur Kinder- und Jugendmedizin Recruiting
Grunwald, Germany, 82031
Medizinische Hochschule Hannover Recruiting
Hannover, Germany, 30625
SRH Kurpfalzkrankenhaus Heidelberg Recruiting
Heidelberg, Germany, 69123
Labor Dr. Reising-Ackermann und Partner Not yet recruiting
Leipzig, Germany, 04289
Donaustrasse 78 Recruiting
Memmingen, Germany, 87700
Praxis Dr. Autenrieth Recruiting
Metzingen, Germany, 72555
Stauferklinikum Schwaebisch Gmuend Recruiting
Mutlangen, Germany, 73557
Hämophilie-Zentrum Rhein Main GmbH Recruiting
Mörfelden-Walldorf, Germany, 64546
Asklepios Fachklinikum Stadtroda GmbH Active, not recruiting
Stadtroda, Germany, 07646
Klinikum Stuttgart Recruiting
Stuttgart, Germany, 70176
Universitaetsklinik fuer Kinder- und Jugendmedizin Recruiting
Tuebingen, Germany, 72076
Stiftung Deutsche Klinik fur Diagnostik GmbH Recruiting
Wiesbaden, Germany, 65191
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00895037     History of Changes
Other Study ID Numbers: 3082B2-4420, B1831016
Study First Received: May 1, 2009
Last Updated: May 20, 2015
Health Authority: Germany: Paul-Ehrlich-Institut

Additional relevant MeSH terms:
Hemophilia A
Blood Coagulation Disorders
Blood Coagulation Disorders, Inherited
Coagulation Protein Disorders
Genetic Diseases, Inborn
Hematologic Diseases
Hemorrhagic Disorders
Factor VIII
Coagulants
Hematologic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on May 25, 2015