Registry For Patients Treated With BeneFix In Usual Care Setting In Germany

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:
NCT00714415
First received: July 8, 2008
Last updated: September 4, 2014
Last verified: September 2014
  Purpose

The purpose of this observational study is to describe the incidence of adverse events among patients treated with BeneFix® in usual health care settings in Germany.


Condition Intervention
Hemophilia B
Drug: BeneFIX

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pharmacovigilance Evaluation Of BeneFIX

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 month ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: February 2008
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
A
Patients with Hemophilia B
Drug: BeneFIX
Patients will be treated in accordance with the requirements of the labeling of BeneFIX in Germany. The dosage and duration of therapy is to be determined by the physician to meet the patients' individual needs for treatment.

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 B

Criteria

Inclusion Criteria:

  • Patients with hemophilia B already receiving or starting treatment with reformulated BeneFIX®.

Exclusion Criteria:

  • Patients with hemophilia B treated with a product other than BeneFIX®.
  • Inclusion in the ongoing prospective registry of European hemophilia B patients using BeneFIX®.
  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: NCT00714415

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

Locations
Austria
Pfizer Investigational Site Recruiting
Linz, Austria, 4020
Germany
Pfizer Investigational Site Recruiting
Hannover, Niedersachsen, Germany, 30159
Pfizer Investigational Site Recruiting
Muenster, Nordrhein-Westfalen, Germany, 48143
Pfizer Investigational Site Recruiting
Berlin, Germany, 13353
Pfizer Investigational Site Recruiting
Berlin, Germany, 10249
Pfizer Investigational Site Recruiting
Blaubeuren, Germany, 89143
Pfizer Investigational Site Recruiting
Bonn, Germany, 53127
Pfizer Investigational Site Recruiting
Brannenburg, Germany, 83098
Pfizer Investigational Site Recruiting
Bremen, Germany, 28177
Pfizer Investigational Site Recruiting
Delmenhorst, Germany, 27753
Pfizer Investigational Site Recruiting
Duesseldorf, Germany, 40225
Pfizer Investigational Site Recruiting
Duisburg, Germany, 47051
Pfizer Investigational Site Recruiting
Halle, Germany, 06120
Pfizer Investigational Site Recruiting
Hamburg, Germany, 20246
Pfizer Investigational Site Recruiting
Hamburg, Germany, 20251
Pfizer Investigational Site Recruiting
Heidelberg, Germany, 69123
Pfizer Investigational Site Recruiting
Koeln, Germany, 50677
Pfizer Investigational Site Recruiting
Memmingen, Germany, 87700
Pfizer Investigational Site Recruiting
Muenchen, Germany, 80337
Pfizer Investigational Site Recruiting
Tuebingen, Germany, 72076
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: NCT00714415     History of Changes
Other Study ID Numbers: 3090A1-4406, B1821011
Study First Received: July 8, 2008
Last Updated: September 4, 2014
Health Authority: Germany: Paul-Ehrlich-Institut

Additional relevant MeSH terms:
Hemophilia B
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn
Genetic Diseases, X-Linked

ClinicalTrials.gov processed this record on September 18, 2014