Personalized Prediction of Tolerance and Immunogenicity in Hemophilia

Status unconfirmed

Conditions studied: Hemophilia A

In brief

This study is designed to accurately identify the pharmacogenetic determinants of risk of Factor VIII (FVIII) inhibitor development by focusing on only a select group of Hemophilia A (HA) patients who have: (i) received a recombinant FVIII therapeutic product containing the same primary amino acid sequence since their original diagnosis; (ii) verifiable FVIII infusion histories; and (iii) been tested regularly for FVIII inhibitor development.

Key facts

Study ID

NCT01626105

Run by

Victor J Marder, M.D.

People needed

55

Starts

2012-06-01

Expected to finish

2014-06-01

Last updated by the study team

2012-07-26

Who can join

Age: 2 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Patients with severe or moderately severe hemophilia A (HA) who have since birth been treated with only a single Factor VIII product (i.e., FVIII protein molecules containing only one primary amino acid sequence).

You may not qualify if…

• HA patients with severities other than severe or moderately severe.
• Hemophilia B patients.
• HA patients who have been treated with more than one FVIII product.
• HA patients who have been treated with more than one FVIII product.
• HA patients who do not have verifiable infusion histories.
• HA patients who lack documentable inhibitor testing \& infusion histories.

Where it is running

• Children's Hospital of Michigan — Detroit, Michigan, United States

Full record on ClinicalTrials.gov

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