Treatment of Hemophilia A Patients With FVIII Inhibitors
Recruiting now
Conditions studied: Hemophilia A
In brief
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.
Key facts
- Study ID
- NCT04023019
- Run by
- Emory University
- People needed
- 120
- Starts
- 2020-03-17
- Expected to finish
- 2029-06-01
- Last updated by the study team
- 2025-09-05
Who can join
Age: any. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Arthur M. Blank Hospital — Atlanta, Georgia, United States (enrolling)
- HZRM Hämophilie-Zentrum Rhein Main — Mörfelden-Walldorf, Germany (enrolling)
Full record on ClinicalTrials.gov
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