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Hematologic Disorders : Type A haemophilia
This study evaluates the treatment of severe hemophilia A with an inhibitor. Haemophilia A (clotting factor VIII deficiency) occurs at about 1 in 5,000–10,000 male births. When a person with hemophilia is injured, he does not bleed harder or faster than a person without hemophilia, he bleeds longer. Small cuts or surface bruises are usually not a problem, but more traumatic injuries may result in serious problems and potential disability (called "bleeding episodes").
When there is an inhibitor against factor VIII (FVIII) the body is not able to use infused FVIII to stop bleeding. This inhibitor slows the function of FVIII so that treatment becomes very difficult. An inhibitor is a serious and very severe complication of hemophilia. Inhibitors must be treated as soon as possible to return the patient’s immune system to a state in which it again accepts treatments with FVIII concentrates. This is called immune tolerance induction (ITI).
Patients with FVIII inhibitors are frequently treated with “immune tolerance induction.” Immune tolerance (IT) means that the body can accept FVIII, and that FVIII is again effective in controlling bleeds. Immune tolerance is obtained by giving high doses of FVIII regularly, until the inhibitor disappears. However, immune tolerance induction is not always effective, and in at least 20% of patients, the inhibitor does not disappear.
There are two types of FVIII concentrates: FVIII concentrates derived from human plasma which contains the Von Willebrand factor (VWF), and concentrates which do not contain the Von Willebrand factor. These two classes of concentrates are commonly used to induce immune tolerance in patients with type A hemophilia.
It has been suggested that FVIII concentrates containing the Von Willebrand factor might improve the results of immune tolerance induction. The principal aim of this study is to test whether or not this is true.
To compare the use of FVIII containing VWF concentrates (FVIII/VWF) to FVIII without VWF for the treatment of FVIII inhibitors. The study team would like to see which one works more often and which one works faster at inducing immune tolerance to FVIII.
For the current eligibility status of this clinical study, referring physicians must contact St. Jude Children's Research Hospital at 1-866-2ST-JUDE (1-866-278-5833).
Ulrike Reiss, MD
St. Jude Children’s Research Hospital
262 Danny Thomas Place
Memphis, TN 38105 USA
Voice: 1-866-2ST-JUDE (1-866-278-5833)
Referring or consulting physicians only: firstname.lastname@example.org
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