Study Evaluating Pharmacovigilance Of Refacto AF

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Pfizer
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00895037
First received: May 1, 2009
Last updated: September 8, 2014
Last verified: September 2014
  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: Pharmacovigilance Evaluation Of Refacto AF In Germany And Austria

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: 180
Study Start Date: November 2009
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2015 (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

Genders Eligible for Study:   Male
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
Pfizer Investigational Site Recruiting
Graz, Austria, 8036
Pfizer Investigational Site Recruiting
Linz, Austria, 4020
Pfizer Investigational Site Recruiting
Wien, Austria, 1090
Germany
Pfizer Investigational Site Recruiting
Munster, NRW, Germany, 48143
Pfizer Investigational Site Recruiting
Berlin, Germany, 10249
Pfizer Investigational Site Recruiting
Bremen, Germany, 28205
Pfizer Investigational Site Recruiting
Duesseldorf, Germany, 40225
Pfizer Investigational Site Recruiting
Duisburg, Germany, 47051
Pfizer Investigational Site Not yet recruiting
Eislingen, Germany, 73054
Pfizer Investigational Site Recruiting
Frankfurt a. M., Germany, 60596
Pfizer Investigational Site Recruiting
Hannover, Germany, 30625
Pfizer Investigational Site Recruiting
Heidelberg, Germany, 69123
Pfizer Investigational Site Not yet recruiting
Leipzig, Germany, 04289
Pfizer Investigational Site Recruiting
Memmingen, Germany, 87700
Pfizer Investigational Site Recruiting
Metzingen, Germany, 72555
Pfizer Investigational Site Recruiting
Mutlangen, Germany, 73557
Pfizer Investigational Site Completed
Stadtroda, Germany, 07646
Pfizer Investigational Site Recruiting
Stuttgart, Germany, 70176
Pfizer Investigational Site Recruiting
Tuebingen, Germany, 72076
Pfizer Investigational Site 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: September 8, 2014
Health Authority: Germany: Paul-Ehrlich-Institut

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
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 29, 2014