Study to Describe the Allergic Reactions to Factor IX in Patients With Hemophilia B
Public ClinicalTrials.gov record NCT00195221. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT00195221
- Recruitment status
- Completed
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 166 participants
Conditions and interventions
Conditions
Interventions
Not listed
Eligibility (public fields only)
- Age range
- Not listed
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 2005 (Type not available)
- Primary completion
- Not listed
- Completion
- Nov 2007 (Actual)
- Last update posted
- Dec 5, 2007
2005 – 2007
United States locations
- U.S. sites
- 15
- U.S. states
- 14
- U.S. cities
- 15
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Not listed | Phoenix | Arizona | 85016 | — |
| Not listed | Orange | California | 92868 | — |
| Not listed | Atlanta | Georgia | 30322 | — |
| Not listed | Boise | Idaho | 83712 | — |
| Not listed | Peoria | Illinois | 61614 | — |
| Not listed | Iowa City | Iowa | 52242 | — |
| Not listed | East Lansing | Michigan | 48823 | — |
| Not listed | Rochester | Minnesota | 55905 | — |
| Not listed | New Brunswick | New Jersey | 08903 | — |
| Not listed | Dayton | Ohio | 45404-1815 | — |
| Not listed | Philadelphia | Pennsylvania | 19104 | — |
| Not listed | Memphis | Tennessee | 38105 | — |
| Not listed | Fort Worth | Texas | 76104 | — |
| Not listed | San Antonio | Texas | 78207 | — |
| Not listed | Seattle | Washington | 98105 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 23 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00195221, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Dec 5, 2007 · Synced Oct 26, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00195221 live on ClinicalTrials.gov.