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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00178607
First Posted: September 15, 2005
Last Update Posted: May 12, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Miguel Escobar, The University of Texas Health Science Center, Houston
  Purpose
To correlate the Human Leukocyte Antigen type and genetic defect with hemophilia A.

Condition
Hemophilia A

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Covalent Tolerance Induction to Factor VIII-Prediction of Inhibitors in Hemophilia

Resource links provided by NLM:


Further study details as provided by Miguel Escobar, The University of Texas Health Science Center, Houston:

Primary Outcome Measures:
  • Inactivation of antibodies by the FVIII covalent reactive analogs [ Time Frame: 6 months ]

Biospecimen Retention:   Samples With DNA
Serum and Plasma

Enrollment: 99
Study Start Date: August 2002
Study Completion Date: October 2015
Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Detailed Description:
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
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 99 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Subjects with Severe Hemophilia A and a positive inhibitor
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00178607


Locations
United States, Texas
The Univeristy of Texas Health Science Center at Houston
Houston, Texas, United States, 77030
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Investigators
Principal Investigator: Miguel Escobar, MD The University of Texas Health Science Center, Houston
  More Information

Responsible Party: Miguel Escobar, Associate Professor - Gulf States Hemophilia Center, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT00178607     History of Changes
Other Study ID Numbers: Inhibitors
First Submitted: September 12, 2005
First Posted: September 15, 2005
Last Update Posted: May 12, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The data will be analyzed and published

Keywords provided by Miguel Escobar, The University of Texas Health Science Center, Houston:
Inhibitors

Additional relevant MeSH terms:
Hemophilia A
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn
Factor VIII
Coagulants