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Treatment of Hemophilia A Patients With FVIII Inhibitors

Recruitingn/aAges any - anyMaleEmory University
NCT04023019 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

This is a non-interventional, multicenter, observational, international study in male persons with haemophilia A who have developed inhibitors to any replacement coagulation factor VIII (FVIII) product. The purpose of the study is to capture different approaches in the management of persons with haemophilia A and FVIII inhibitors, document current immune tolerance induction approaches, and evaluate the efficacy and safety of immune tolerance induction, including the combination of FVIII and emicizumab. Patients will be assigned to 1 of 3 groups based on the treatments they receive, and may switch to another group if their treatment is changed. Participants will be followed after a maximum observational period of 5 years.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Male persons with haemophilia A, of any severity, who have a historical inhibitor titer ≥ 0.6 BU/mL, including those who have failed previous immune tolerance induction (ITI) attempt(s) * Persons undergoing ITI with Nuwiq, octanate, or wilateor undergoing ITI with Nuwiq®, octanate® or wilate® and receiving prophylactic therapy with emicizumab, activated prothrombin complex concentrate (aPCC), or activated recombinant factor VII (rFVIIa) * Participants or participants' parent(s)/legal guardian(s) must be capable of giving signed informed consent and be able to understand the trial documents Exclusion Criteria: * Participants are excluded from the trial if any coagulation disorder other than haemophilia A is diagnosed * Partly retrospective patients will be excluded if detailed documentation on treatment, all bleeding episodes, inhibitor titers, and FVIII levels is not available for the retrospective period
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What it tests

  • Nuwiq
  • Octanate
  • Wilate
  • Emicizumab
  • Recombinant factor VIIa (rFVIIa)
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Where

2 sites
Arthur M. Blank Hospital
Atlanta, United States
HZRM Hämophilie-Zentrum Rhein Main
Mörfelden-Walldorf, Germany
🤝 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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