Treatment of Hemophilia A Patients With FVIII Inhibitors
MOdern Treatment of Inhibitor-PositiVe PATiEnts With Haemophilia A - An International Observational Study
- Hemophilia A
At a glance
- Phase
- Phase not stated
- Study type
- Observational
- Sponsor
- Emory University
- Enrolment target
- 120
- Started
- 17 March 2020
- Main results due
- December 2028
- Study sites
- 2
- Registry updated
- 23 September 2026
Can you take part?
- No age limit is stated.
- Men only.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full eligibility criteria
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
What this study is about
In the sponsor’s own words, from the registry.
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.
Study sites(2)
Arthur M. Blank Hospital
Atlanta, Georgia, United States
Recruiting
HZRM Hämophilie-Zentrum Rhein Main
Mörfelden-Walldorf, Germany
Recruiting
Showing 2 of 2 sites. 2 of the 2 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT04023019. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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