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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	19 February 2015
Main ID:	NCT00195221
Date of registration:	12/09/2005
Prospective Registration:	No
Primary sponsor:	Wyeth is now a wholly owned subsidiary of Pfizer
Public title:	Study to Describe the Allergic Reactions to Factor IX in Patients With Hemophilia B
Scientific title:	A Retrospective Study to Describe the Incidence of Moderate to Severe Allergic Reactions to Factor IX in Patients With Hemophilia B
Date of first enrolment:	February 2005
Target sample size:	166
Recruitment status:	Completed
URL:	http://clinicaltrials.gov/show/NCT00195221
Study type:	Observational
Study design:	Time Perspective: Retrospective
Phase:

Countries of recruitment
Austria	Belgium	Canada	France	Germany	Italy	Spain	United Kingdom
United States

Contacts

Name:	Trial Manager
Address:
Telephone:
Email:
Affiliation:	For Italy, decresg@wyeth.com

Name:	Trial Manager
Address:
Telephone:
Email:
Affiliation:	For UK, ukmedinfo@wyeth.com

Name:	Medical Monitor
Address:
Telephone:
Email:
Affiliation:	Wyeth is now a wholly owned subsidiary of Pfizer

Name:	Trial Manager
Address:
Telephone:
Email:
Affiliation:	For Austria, WPVIMED@wyeth.com

Name:	Trial Manager
Address:
Telephone:
Email:
Affiliation:	For Germany, MedInfoDEU@wyeth.com

Key inclusion & exclusion 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.

Age minimum: N/A
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Hemophilia B

Allergic Reactions

Intervention(s)

Primary Outcome(s)

Secondary Outcome(s)

Secondary ID(s)

3090A-101657

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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