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Assessing Different FVIII Doses and Frequencies in Immune Tolerance Induction (ITI) with ADVATE Among Hemophilia a Boys with Inhibitor (INITIATE Study)

RecruitingPhase 4Ages 0 Years - 18 YearsMaleRunhui WU
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In plain words

What the trial is, and whether it could suit you

Hemophilia A is a blood coagulation disorder caused by deficient or dysfunctional clotting factor VIII (FVIII) leading to incomplete haemostasis. Patients with severe Hemophilia A are predisposed to recurrent bleeding episodes (BEs) in joints and soft tissues that culminate in debiltating arthropathy and long-term morbidity. Prophylaxis with plasma-derived or recombinant FVIII concentrates effectively restores FVIII levels in patients with Hemophilia A, and significantly reduces the risk of bleeding. A critical concern for patients receiving FVIII replacement therapy is the development of neutralising antibodies (inhibitors) against the treatment. Inhibitors develop in up to 40% of patients with severe Hemophilia A when first exposed to FVIII treatment, typically within the first 20-30 exposure days (EDs) although a residual risk remains until after 75 EDs. Inhibitors preclude the use of

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📋 Eligibility rules (as published)
Inclusion Criteria: * Severe hemophilia A (FⅧ:C \<2%); * Positive for FVIII inhibitors; * No allergic reactions to FVIII concentrates. Exclusion Criteria: * Presence of other coagulation-related diseases, * Hematological disorders, * autoimmune diseases * malignancies
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What it tests

  • Advate®
  • Advate®
  • Advate®
  • Advate®
  • Advate®
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Where

1 site
Beijing Children's hospitial
Beijing, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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