Clinical trial NCT00195221: Study to Describe the Allergic Reactions to Factor IX in Patients With Hemophilia B
Official title: A Retrospective Study to Describe the Incidence of Moderate to Severe Allergic Reactions to Factor IX in Patients With Hemophilia B
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hemophilia B
Allergic Reactions
Keywords: Hemophilia B
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-19
Enrollment: 166
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE

Brief 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.


Eligibility 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
state: Arizona
city: Orange
country: United States
state: California
city: Atlanta
country: United States
state: Georgia
city: Boise
country: United States
state: Idaho
city: Peoria
country: United States
state: Illinois
city: Iowa City
country: United States
state: Iowa
city: East Lansing
country: United States
state: Michigan
city: Rochester
country: United States
state: Minnesota
city: New Brunswick
country: United States
state: New Jersey
city: Dayton
country: United States
state: Ohio
city: Philadelphia
country: United States
state: Pennsylvania
city: Memphis
country: United States
state: Tennessee
city: Fort Worth
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Seattle
country: United States
state: Washington
city: Vienna
country: Austria
city: Brussels
country: Belgium
city: Montegnee
country: Belgium
city: Calgary
country: Canada
state: Alberta
city: Liffre
country: France
city: Montmorency
country: France
city: Paris
country: France
city: Strasbourg
country: France
city: Hamburg
country: Germany
city: Muenster
country: Germany
city: Catania
country: Italy
city: Catanzaro
country: Italy
city: Milano
country: Italy
city: Naples
country: Italy
city: Padova
country: Italy
city: Palermo
country: Italy
city: Parma
country: Italy
city: Perugia
country: Italy
city: Vicenza
country: Italy
city: Valencia
country: Spain
city: Valladolid
country: Spain
city: Wolverhampton
country: United Kingdom
state: Wstmid
city: Cardiff
country: United Kingdom
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
affiliation: For Germany, MedInfoDEU@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For Austria, WPVIMED@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For UK, ukmedinfo@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For Italy, decresg@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
References: