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

NCT00195221

Last updated date
Study Location
Phoenix, Arizona, 85016, United States
Contact
1-800-718-1021

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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.

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Hemophilia B, Allergic ReactionsStudy to Describe the Allergic Reactions to Factor IX in Patients With Hemophilia B NCT00195221
  1. Phoenix, Arizona
  2. Orange, California
  3. Atlanta, Georgia
  4. Boise, Idaho
  5. Peoria, Illinois
  6. Iowa City, Iowa
  7. East Lansing, Michigan
  8. Rochester, Minnesota
  9. New Brunswick, New Jersey
  10. Dayton, Ohio
  11. Philadelphia, Pennsylvania
  12. Memphis, Tennessee
  13. Fort Worth, Texas
  14. San Antonio, Texas
  15. Seattle, Washington
  16. Vienna,
  17. Brussels,
  18. Montegnee,
  19. Calgary, Alberta
  20. Liffre,
  21. Montmorency,
  22. Paris,
  23. Strasbourg,
  24. Hamburg,
  25. Muenster,
  26. Catania,
  27. Catanzaro,
  28. Milano,
  29. Naples,
  30. Padova,
  31. Palermo,
  32. Parma,
  33. Perugia,
  34. Vicenza,
  35. Valencia,
  36. Valladolid,
  37. Wolverhampton, Wstmid
  38. Cardiff,
ALL GENDERS
0+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title 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
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.

Detailed Description Not Provided
Study Type Observational
Study Design Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Not Provided
Study Population Not Provided
Condition
  • Hemophilia B
  • Allergic Reactions
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Enrollment
 (submitted: September 12, 2005)
166
Original Enrollment Same as current
Actual Study Completion Date November 2007
Primary Completion Date Not Provided
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.
Sex/Gender
Sexes Eligible for Study:All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Austria,   Belgium,   Canada,   France,   Germany,   Italy,   Spain,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00195221
Other Study ID Numbers 3090A-101657
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Not Provided
Study Sponsor Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators Not Provided
Investigators
Study Director:Medical MonitorWyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator:Trial ManagerFor Germany, [email protected]
Principal Investigator:Trial ManagerFor Austria, [email protected]
Principal Investigator:Trial ManagerFor UK, [email protected]
Principal Investigator:Trial ManagerFor Italy, [email protected]
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date December 2007