You are here

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

Last updated on May 12, 2018

FOR MORE INFORMATION
Study Location
Phoenix, Arizona, 85016 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Hemophilia B, Allergic Reactions
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
0+
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- There are no exclusion criteria.

NCT00195221
Pfizer
Completed
Study to Describe the Allergic Reactions to Factor IX in Patients With Hemophilia B

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

Try a new search

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your zip code, city, or country to find studies near you.
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.

Not Provided
Observational
Time Perspective: Retrospective
Not Provided
Not Provided
Not Provided
Not Provided
  • Hemophilia B
  • Allergic Reactions
Not Provided
Not Provided
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
166
November 2007
Not Provided

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.
Sexes Eligible for Study: All
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
Austria,   Belgium,   Canada,   France,   Germany,   Italy,   Spain,   United Kingdom,   United States
 
 
NCT00195221
3090A-101657
Not Provided
Not Provided
Not Provided
Not Provided
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator: Trial Manager For Germany, [email protected]
Principal Investigator: Trial Manager For Austria, [email protected]
Principal Investigator: Trial Manager For UK, [email protected]
Principal Investigator: Trial Manager For Italy, [email protected]
Wyeth is now a wholly owned subsidiary of Pfizer
December 2007

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



Call Now