Plain-English translation of NCT02207894 on ClinicalTrials.gov ↗ · Source last updated · Translation generated · How we translate trials
This is an observational study — meaning researchers will collect and analyze data from patients already receiving immune tolerance induction (ITI), a proven treatment approach that uses high-dose factor VIII replacement therapy to help the body accept the clotting factor instead of fighting it with antibodies. The study will track how well this treatment works when doctors personalize their choice of clotting factor concentrates (the medications used) based on each patient's individual needs.
About one-third of people with moderate to severe hemophilia A develop inhibitors — antibodies that block their clotting factor replacement therapy, making bleeds harder to control. This treatment has shown promise in earlier research, but the study aims to gather real-world data on how successful it is when doctors tailor the specific medication choice to each patient's situation.
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This is an observational study, so you will not be randomly assigned to a new treatment — instead, researchers will document and track the immune tolerance induction therapy your doctor has already decided you need. You will share medical data and records about your inhibitor levels, bleeds, and response to treatment over time. The study will follow you from when your inhibitor is first detected through your treatment course.
AI-generated summary from trial data · Jun 3, 2026 · Not medical advice
Germany
Sponsor
Haemophilia Centre Rhine Main
Collaborators
University of Bonn, Skane University Hospital
Enrollment target
~300 participants
Started
August 2006
Primary completion
December 2027
Sex
Male only
Last updated on clinicaltrials.gov in April 2026.
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Central contact
Carmen Escuriola Ettingshausen, MD
Director HZRM
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