Study Evaluating Inhibitor Specificity in Hemophilia A

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NCT00151385

Last updated on May 12, 2018

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About this Study

This investigation will utilize a systematic determination of anti-FVIII antibody specificity
in PTPs (> 50 ED) with hemophilia A who have developed inhibitors in response to treatment
with any FVIII product(s). A group of patients with hemophilia A, who have no evidence of
current or prior FVIII inhibitor will be included for comparison. The objective of this study
is to describe the patterns of antibodies and associated epitopes in the study population.

Study Location

Atlanta, Georgia, 30322 United States

See other locations

Contact

1-800-718-1021

[email protected]

Eligibility criteria

Condition

Hemophilia A

Sex

Females and Males

Age

Inclusion criteria

Show details

· Patients with moderate or severe congenital hemophilia A, a current FVIII inhibitor, who
have taken at least two different FVIII products during their lifetime.

Exclusion criteria

Show details

- Patients who have had an inhibitor prior to their current inhibitor.

- Patients with immune disorders.

NCT00151385

Pfizer

Withdrawn

Study Evaluating Inhibitor Specificity in Hemophilia A

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Descriptive Information

Brief Title ^ICMJE

Study Evaluating Inhibitor Specificity in Hemophilia A

Official Title ^ICMJE

A Multicenter Study to Describe the Immunogenic Epitope(s) of Factor VIII in Previously Treated Patients With Congenital Hemophilia A Who Develop De Novo Factor VIII Inhibitors While Receiving Factor VIII Infusion Therapy.

Brief Summary

This investigation will utilize a systematic determination of anti-FVIII antibody specificity in PTPs (> 50 ED) with hemophilia A who have developed inhibitors in response to treatment with any FVIII product(s). A group of patients with hemophilia A, who have no evidence of current or prior FVIII inhibitor will be included for comparison. The objective of this study is to describe the patterns of antibodies and associated epitopes in the study population.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic

Condition ^ICMJE

Hemophilia A

Intervention ^ICMJE

Procedure: single blood draw

Study Arms

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 ^ICMJE

Withdrawn

Enrollment ^ICMJE

Completion Date

October 2007

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

Inclusion Criteria:

· Patients with moderate or severe congenital hemophilia A, a current FVIII inhibitor, who have taken at least two different FVIII products during their lifetime.

Exclusion Criteria:

Patients who have had an inhibitor prior to their current inhibitor.
Patients with immune disorders.

Sex/Gender

Sexes Eligible for Study:

All

Ages

Child, Adult, Senior

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

Belgium, France, Germany, Italy, Spain, United Kingdom, United States

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00151385

Other Study ID Numbers ^ICMJE

3082A-101342

Has Data Monitoring Committee

Not Provided

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Wyeth is now a wholly owned subsidiary of Pfizer

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:	Medical Monitor	Wyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator:	Trail Manager	For Italy, [email protected]
Principal Investigator:	Trial Manager	For Spain, [email protected]
Principal Investigator:	Trial Manager	For UK, [email protected]
Principal Investigator:	Trial Manager	For Belgium, [email protected]
Principal Investigator:	Trial Manager	For Germany, [email protected]

PRS Account

Wyeth is now a wholly owned subsidiary of Pfizer

Verification Date

June 2012

^ICMJE Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

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NCT00151385

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Study Evaluating Inhibitor Specificity in Hemophilia A

NCT00151385

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