Actively Recruiting
Treatment of Hemophilia A Patients With FVIII Inhibitors
Led by Emory University · Updated on 2025-09-05
120
Participants Needed
2
Research Sites
480 weeks
Total Duration
On this page
Sponsors
E
Emory University
Lead Sponsor
O
Octapharma
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Treatment of Hemophilia A Patients With FVIII Inhibitors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male persons with haemophilia A, any severity, with a historical inhibitor titer 0.6 BU/mL, including those who failed previous immune tolerance induction attempts
- Currently undergoing immune tolerance induction with Nuwiq, octanate, or wilate, or undergoing immune tolerance induction with these plus prophylactic emicizumab, aPCC, or rFVIIa
- Able to give signed informed consent and understand trial documents (participant or parent/legal guardian)
You will not qualify if you...
- Diagnosis of any coagulation disorder other than haemophilia A
- Partly retrospective patients without detailed documentation on treatment, bleeding episodes, inhibitor titers, and FVIII levels for the retrospective period
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Arthur M. Blank Hospital
Atlanta, Georgia, United States, 30329
Actively Recruiting
2
HZRM Hämophilie-Zentrum Rhein Main
Mörfelden-Walldorf, Germany, 64546
Actively Recruiting
Research Team
R
Robert Sidonio, MD, MSc
CONTACT
C
Carmen Escuriola-Ettingshausen, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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