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

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

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.

Study Overview

Status

Completed

Study Type

Observational

Enrollment

166

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Vienna, Austria, 1090
      • Brussels, Belgium
      • Montegnee, Belgium, 4420
    • Alberta
      • Calgary, Alberta, Canada, T2N2T9
      • Liffre, France, 35340
      • Montmorency, France, 95160
      • Paris, France, 75014
      • Strasbourg, France, 67098
      • Hamburg, Germany, HH20246
      • Muenster, Germany, D-48413
      • Catania, Italy, 95124
      • Catanzaro, Italy, 88100
      • Milano, Italy, 20162
      • Naples, Italy, 5-80131
      • Padova, Italy, 35128
      • Palermo, Italy, 90100
      • Parma, Italy, 43100
      • Perugia, Italy, 06100
      • Vicenza, Italy, 36100
      • Valencia, Spain, 46009
      • Valladolid, Spain, 47004
      • Cardiff, United Kingdom, CF14 4XN
    • Wstmid
      • Wolverhampton, Wstmid, United Kingdom, WV10 0QP
    • Arizona
      • Phoenix, Arizona, United States, 85016
    • California
      • Orange, California, United States, 92868
    • Georgia
      • Atlanta, Georgia, United States, 30322
    • Idaho
      • Boise, Idaho, United States, 83712
    • Illinois
      • Peoria, Illinois, United States, 61614
    • Iowa
      • Iowa City, Iowa, United States, 52242
    • Michigan
      • East Lansing, Michigan, United States, 48823
    • Minnesota
      • Rochester, Minnesota, United States, 55905
    • New Jersey
      • New Brunswick, New Jersey, United States, 08903
    • Ohio
      • Dayton, Ohio, United States, 45404-1815
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
    • Tennessee
      • Memphis, Tennessee, United States, 38105
    • Texas
      • Fort Worth, Texas, United States, 76104
      • San Antonio, Texas, United States, 78207
    • Washington
      • Seattle, Washington, United States, 98105

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Trial Manager, For Austria, WPVIMED@wyeth.com
  • Principal Investigator: Trial Manager, For Italy, decresg@wyeth.com

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2005

Study Completion (Actual)

November 1, 2007

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (Estimate)

September 19, 2005

Study Record Updates

Last Update Posted (Estimate)

December 5, 2007

Last Update Submitted That Met QC Criteria

December 3, 2007

Last Verified

December 1, 2007

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hemophilia B

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