CClinicalTrials.gg
CompletedNCT00195221Updated Dec 5, 2007

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

An observational study in Hemophilia B and Allergic Reactions, sponsored by Wyeth is now a wholly owned subsidiary of Pfizer. Completed at 38 sites in 9 countries. Per ClinicalTrials.gov, last updated 2007-12-05.

Sponsored by Wyeth is now a wholly owned subsidiary of Pfizer · Observational

Study type
Observational
Time perspective
Retrospective
Enrollment
166
Sex
All
01

Study 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.

02

Conditions studied

  • Hemophilia B
  • Allergic Reactions

Keywords

  • Hemophilia B
03

In context

Hemophilia A

866 studies on the registry are indexed under Hemophilia A; 137 are open to participants now.

This study's enrollment of 166 is above the median of 80 across 314 observational studies indexed under Hemophilia A.

Browse Hemophilia A studies →

Lead sponsor

Wyeth is now a wholly owned subsidiary of Pfizer is the lead sponsor of 472 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • There are no exclusion criteria.
05

Study design

Time perspective
Retrospective
Enrollment
166 participants
06

Study locations

38 sites
  • Phoenix, Arizona 85016, United States
  • Orange, California 92868, United States
  • Atlanta, Georgia 30322, United States
  • Boise, Idaho 83712, United States
  • Peoria, Illinois 61614, United States
  • Iowa City, Iowa 52242, United States
  • East Lansing, Michigan 48823, United States
  • Rochester, Minnesota 55905, United States
  • New Brunswick, New Jersey 08903, United States
  • Dayton, Ohio 45404-1815, United States
  • Philadelphia, Pennsylvania 19104, United States
  • Memphis, Tennessee 38105, United States
  • Fort Worth, Texas 76104, United States
  • San Antonio, Texas 78207, United States
  • Seattle, Washington 98105, United States
  • Vienna, 1090, Austria
  • Brussels, Belgium
  • Montegnee, 4420, Belgium
  • Calgary, Alberta T2N2T9, Canada
  • Liffre, 35340, France
  • Montmorency, 95160, France
  • Paris, 75014, France
  • Strasbourg, 67098, France
  • Hamburg, HH20246, Germany
  • Muenster, D-48413, Germany
  • Catania, 95124, Italy
  • Catanzaro, 88100, Italy
  • Milano, 20162, Italy
  • Naples, 5-80131, Italy
  • Padova, 35128, Italy
  • Palermo, 90100, Italy
  • Parma, 43100, Italy
  • Perugia, 06100, Italy
  • Vicenza, 36100, Italy
  • Valencia, 46009, Spain
  • Valladolid, 47004, Spain
  • Wolverhampton, Wstmid WV10 0QP, United Kingdom
  • Cardiff, CF14 4XN, United Kingdom
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 5, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00195221
Lead sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
First posted
Sep 19, 2005
Start date
Feb 2005
Completion
Nov 2007
Last update
Dec 5, 2007

Study contacts

Medical Monitor
study director · Wyeth is now a wholly owned subsidiary of Pfizer
Trial Manager
principal investigator · For Germany, MedInfoDEU@wyeth.com
Trial Manager
principal investigator · For Austria, WPVIMED@wyeth.com
Trial Manager
principal investigator · For UK, ukmedinfo@wyeth.com
Trial Manager
principal investigator · For Italy, decresg@wyeth.com
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2007. You cannot join it, but the record below documents what was studied.

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