- * Male subjects diagnosed with haemophilia A (≤ 2% FVIII level in the absence of factor replacement, according to their medical history).
- * Age 28 days to \<12 years.
- * Subject is eligible for immune tolerance induction (ITI) therapy
Hemophilia A
Study of Biostate for Treatment of Children With Hemophilia A Complicated by Antibody Development
NCT01445197 | PHASE 3 | INTERVENTIONAL
This is a clinical study to investigate how well Biostate works in treatment of male patients below the age of 12 years who have a clotting factor deficiency that is aggravated by the development of antibodies. The antibodies are directed against the clotting factor that is given for replacement therapy and usually make therapy unsuccessful. The treatment used in this study is called immune tolerance therapy.
Trial Information
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Study Site
Vienna,Austria
Study Site
Frankfurt,Germany
Study Site
Hamburg,Germany
Study Site
Athens,Greece
Study Site
Thessaloniki,Greece
Study Site
Milano,Italy
Study Site
Barnaul,Russian Federation
Study Eligibility Criteria
Additional Studies
Additional studies can be found at ClinicalTrials.gov