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NCT00195221 · ClinicalTrials.gov registry record
Study to Describe the Allergic Reactions to Factor IX in Patients With Hemophilia B
A clinical trial, sponsored by Wyeth is now a wholly owned subsidiary of Pfizer.
- Completed
- Registry status
- 166
- Enrollment target
NCT00195221: Completed study, sponsored by Wyeth is now a wholly owned subsidiary of Pfizer.
NCT00195221 is a clinical trial that has completed, run by Wyeth is now a wholly owned subsidiary of Pfizer. The registered enrollment target is 166 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00195221 has completed, sponsored by Wyeth is now a wholly owned subsidiary of Pfizer.
- COMPLETED
- Registry status
- 166 participants
- Enrollment target
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.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 166 participants |
| Start Date | 2005-02 |
| Est. Completion | 2007-11 |
What the finished NCT00195221 record still lists
NCT00195221 is an observational study that tracks outcomes without assigning an intervention. The registered 166 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT00195221 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00195221 about?
NCT00195221 is a clinical study titled "Study to Describe the 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 concentra...
What is the current status of trial NCT00195221?
This trial is currently completed. The enrollment target is 166 participants. The study started on 2005-02. Estimated completion is 2007-11.
Who is sponsoring clinical trial NCT00195221?
This trial is sponsored by Wyeth is now a wholly owned subsidiary of Pfizer, which has 167 total clinical trials registered on ClinicalTrials.gov.
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