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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 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.

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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

FieldValue
Enrollment Target 166 participants
Start Date 2005-02
Est. Completion 2007-11

What the Registry Record Tells You About NCT00195221

The ClinicalTrials.gov registry entry for NCT00195221 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 166 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Wyeth is now a wholly owned subsidiary of Pfizer, which has 167 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 0 interventions.

NCT00195221 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.