Natural History Study of Factor IX Treatment and Complications

Status unconfirmed

Conditions studied: Factor IX Deficiency

In brief

This study will examine two groups of subjects with factor IX (FIX) deficiency: 1) those with a current or history of inhibitors to FIX, and; 2) groups of two or more affected brothers, with or without inhibitors. The overall goal is to characterize the study groups in terms of their medical history, their patterns of bleeding, their care, quality of life, and complications including the development of joint disease, inhibitory antibodies to FIX, use of immune tolerance induction (ITI) and outcome.

Key facts

Study ID

NCT02502409

Run by

Skane University Hospital

People needed

550

Starts

2015-07-01

Expected to finish

2021-12-01

Last updated by the study team

2021-05-25

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• A consent approved by the appropriate Institutional Review Board (IRB)/Independent Ethics Committee (IEC) has been obtained from the subject or his legally acceptable representative
• Subject has FIX deficiency AND
• Is part of an affected brother pair/group that will also enroll; AND/OR
• Has a current or history of inhibitor, defined as >0.6 Bethesda units (BU)

You may not qualify if…

• Subject has another congenital bleeding disorder
• Subject is a carrier of hemophilia B with factor level >0.40 IU/mL

Where it is running

• Indiana Hemophilia & Thrombosis Center — Indianapolis, Indiana, United States

Full record on ClinicalTrials.gov

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