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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by The University of Texas Health Science Center, Houston
Sponsor:
Information provided by (Responsible Party):
Miguel Escobar, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT00178607
First received: September 12, 2005
Last updated: May 16, 2014
Last verified: May 2014
  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 The University of Texas Health Science Center, Houston:

Primary Outcome Measures:
  • Inactivation of antibodies by the FVIII covalent reactive analogs [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Serum and Plasma


Estimated Enrollment: 150
Study Start Date: August 2002
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 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

Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00178607

Contacts
Contact: Madeline Cantini, BSN 713-500-8377 Madeline.Cantini@uth.tmc.edu

Locations
United States, Texas
The Univeristy of Texas Health Science Center at Houston Recruiting
Houston, Texas, United States, 77030
Contact: Madeline Cantini, BSN    713-500-8377    madeline.cantini@uth.tmc.edu   
Principal Investigator: Miguel Escobar, MD         
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

No publications provided

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
Study First Received: September 12, 2005
Last Updated: May 16, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by 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
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 01, 2014