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Covalent Tolerance Induction to Factor VIII-Prediction of Inhibitors in Hemophilia

NCT ID: NCT00178607

Last Updated: 2016-05-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

99 participants

Study Classification

OBSERVATIONAL

Study Start Date

2002-08-31

Study Completion Date

2015-10-31

Brief Summary

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To correlate the Human Leukocyte Antigen type and genetic defect with hemophilia A.

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Detailed Description

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One of the most serious complications of treatment in patients with hemophilia A or hemophilia B is the development of an inhibitor, which is an antibody that neutralizes the factor VIII or IX coagulant activity. Up to one fourth of patients with severe hemophilia A develop an inhibitor but at present it is not possible to predict which patients will develop such antibody. The ability to predict an inhibitor development at an individual level would greatly improve therapeutic approach to this serious problem

Conditions

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Hemophilia A

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Severe Hemophilia A with an inhibitor level of 0.6 B.U. or higher

Exclusion Criteria

* Severe Hemophilia A with a negative inhibitor
Minimum Eligible Age

1 Day

Maximum Eligible Age

99 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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The University of Texas Health Science Center, Houston

OTHER

Sponsor Role lead

Responsible Party

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Miguel Escobar

Associate Professor - Gulf States Hemophilia Center

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Miguel Escobar, MD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Locations

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The Univeristy of Texas Health Science Center at Houston

Houston, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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Inhibitors

Identifier Type: -

Identifier Source: org_study_id

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