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

Completed

Conditions studied: Hemophilia B, Allergic Reactions

In brief

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.

Key facts

Study ID

NCT00195221

Run by

Wyeth is now a wholly owned subsidiary of Pfizer

People needed

166

Starts

2005-02-01

Expected to finish

2007-11-01

Last updated by the study team

2007-12-05

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• There are no exclusion criteria.

Where it is running

• Study site — Phoenix, Arizona, United States
• Study site — Orange, California, United States
• Study site — Atlanta, Georgia, United States
• Study site — Boise, Idaho, United States
• Study site — Peoria, Illinois, United States
• Study site — Iowa City, Iowa, United States
• Study site — East Lansing, Michigan, United States
• Study site — Rochester, Minnesota, United States
• Study site — New Brunswick, New Jersey, United States
• Study site — Dayton, Ohio, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Memphis, Tennessee, United States
• Study site — Fort Worth, Texas, United States
• Study site — San Antonio, Texas, United States
• Study site — Seattle, Washington, United States
• Study site — Vienna, Austria
• Study site — Brussels, Belgium
• Study site — Montegnée, Belgium
• Study site — Calgary, Alberta, Canada
• Study site — Liffré, France
• Study site — Montmorency, France
• Study site — Paris, France
• Study site — Strasbourg, France
• Study site — Hamburg, Germany
• Study site — Münster, Germany

Full record on ClinicalTrials.gov

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