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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00178607

Enrollment

Registered

2005-09-15

Start date

2002-08-31

Completion date

2015-10-31

Last updated

2016-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemophilia A

Keywords

Inhibitors

Brief summary

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

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

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

MALE

Age

1 Days to 99 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Inactivation of antibodies by the FVIII covalent reactive analogs	6 months

Countries

United States

Outcome results