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NCT00195221 Clinical Trial

Study to Describe the Allergic Reactions to Factor IX in Patients With Hemophilia B

Hemophilia B Clinical Trial

Official title:
A Retrospective Study to Describe the Incidence of Moderate to Severe Allergic Reactions to Factor IX in Patients With Hemophilia B

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00195221
Other study ID # 3090A-101657
Secondary ID
Status Completed
Phase Phase 4
First received September 12, 2005
Last updated December 3, 2007
Start date February 2005
Est. completion date November 2007

Study information
Verified date December 2007
Source Wyeth is now a wholly owned subsidiary of Pfizer
Contact n/a
Is FDA regulated No
Health authority European Union: European Medicines Agency
Study type Observational

Clinical Trial Summary

Retrospective, multicenter study in patients with hemophilia B. This study will be placed at 20 to 50 hemophilia treatment centers in North America and the EU, and is designed to estimate the frequency of Class II and III allergic reactions in association with the administration of any FIX concentrate.

Following informed consent and eligibility, historical patient information including demographics, allergy history, hemophilia history, frequency and severity of allergic reaction(s), number of exposure days with products causing allergic reactions, exposure days to blood products including FIX concentrates, treatment for allergic reaction(s), outcome of event(s), any other adverse event(s) occuring within 48 hours of onset of allergic reaction(s), rechallenge and outcome, switch to another FIX product (if applicable) and outcome, current status of patient, and results of any special studies (eg, skin or RAST testing, alloantibody analyses, ect) will be collected.

Recruitment information / eligibility
Status Completed
Enrollment 166
Est. completion date November 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility 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.

Study Design

Time Perspective: Retrospective

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer

Countries where clinical trial is conducted

United States,  Austria,  Belgium,  Canada,  France,  Germany,  Italy,  Spain,  United Kingdom, 

See also
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