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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 17 October 2012
Main ID:  NCT00195221
Date of registration: 12/09/2005
Primary sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Public title: Study to Describe the Allergic Reactions to Factor IX in Patients With Hemophilia B
Scientific title: A Retrospective Study to Describe the Incidence of Moderate to Severe Allergic Reactions to Factor IX in Patients With Hemophilia B
Date of first enrolment: February 2005
Target sample size: 166
Recruitment status: Completed
URL:  http://clinicaltrials.gov/show/NCT00195221
Study type:  Observational
Study design:  Time Perspective: Retrospective  
Countries of recruitment
Austria Belgium Canada France Germany Italy Spain United Kingdom
United States
Contacts
Name:   Trial Manager
Address: 
Telephone:
Email:
Affiliation:  For Austria, WPVIMED@wyeth.com
Name:   Trial Manager
Address: 
Telephone:
Email:
Affiliation:  For Germany, MedInfoDEU@wyeth.com
Name:   Trial Manager
Address: 
Telephone:
Email:
Affiliation:  For Italy, decresg@wyeth.com
Name:   Trial Manager
Address: 
Telephone:
Email:
Affiliation:  For UK, ukmedinfo@wyeth.com
Name:   Medical Monitor
Address: 
Telephone:
Email:
Affiliation:  Wyeth is now a wholly owned subsidiary of Pfizer
Key inclusion & exclusion criteria

Inclusion Criteria:

- Written consent to release patient information

- Living or deceased patients with mild to severe hemophilia B who have had at least 1
exposure to replacement factor IX product(s).

- Living or deceased patients who had their first infusion of any FIX product between 1
January 1991 and 31 December 2003.

Exclusion Criteria:

- There are no exclusion criteria.



Age minimum: N/A
Age maximum: N/A
Gender: Both
Health Condition(s) or Problem(s) studied
Allergic Reactions
Hemophilia B
Intervention(s)
Primary Outcome(s)
Secondary Outcome(s)
Secondary ID(s)
3090A-101657
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
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