Text Size

Prospective Registry of European Hemophilia B Patients Receiving BeneFIX® for Usual Use

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00167973
First received: September 11, 2005
Last updated: May 25, 2010
Last verified: May 2010
History of Changes
  Purpose

This is an open-label multi-center Registry in patients with hemophilia B receiving BeneFIX. All patients who begin treatment with BeneFIX in European Union countries, will be eligible for participation. Patient demographics will be collected at baseline for all patients. A baseline FIX activity and Bethesda assay for inhibitor based on historical data should be recorded if available. Adverse events as defined in the protocol will also be reported on the appropriate forms. Data will be collected from patients on an ongoing basis to ensure that information is being captured for each patient being treated with BeneFIX.


Condition Phase
Hemophilia B
 Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Registry of European Hemophilia B Patients Receiving BeneFIX®(Nonacog Alfa, Recombinant Human Factor IX) for Usual Use

Resource links provided by NLM:

Drug Information available for: Factor IX
U.S. FDA Resources

Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Primary Outcome Measures:
  • Observation for safety [ Time Frame: Study Duration ] [ Designated as safety issue: Yes ]

Enrollment: 218
Study Start Date: January 2002
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

All EU patients beginning treatment with BeneFIX

Criteria

Inclusion Criteria:

  • Patients with Hemophilia B scheduled to begin treatment with BeneFIX are eligible for Registry enrollment

Exclusion Criteria:

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00167973

  Show 91 Study Locations
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator: Trial mANAGER For Germany, MedInfoDEU@wyeth.com
Principal Investigator: Trial Manager For Italy, descresg@wyeth.com
Principal Investigator: Trial Manager For Belgium, trials-BEL@wyeth.com
Principal Investigator: Trial Manager For Netherlands, trials-NL@wyeth.com
Principal Investigator: Trial Manager For Sweden, MedInfoNord@wyeth.com
Principal Investigator: Trial Manager For Austria, WPVIMED@wyeth.com
Principal Investigator: Trial Manager For UK, ukmedinfo@wyeth.com
  More Information

No publications provided

Responsible Party: Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
ClinicalTrials.gov Identifier: NCT00167973     History of Changes
Other Study ID Numbers: 3090A-101039
Study First Received: September 11, 2005
Last Updated: May 25, 2010
Health Authority: European Union: European Medicines Agency

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Hemophilia B

Additional relevant MeSH terms:
Hemophilia B
Hemophilia A
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 May 19, 2013