Actively Recruiting
A Survey on the Success of Inhibitor Elimination Using Individualized Concentrate Selection and Controlled ITI
Led by Haemophilia Centre Rhine Main · Updated on 2026-04-21
300
Participants Needed
1
Research Sites
1113 weeks
Total Duration
On this page
Sponsors
H
Haemophilia Centre Rhine Main
Lead Sponsor
U
University of Bonn
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research program is initiated to evaluate and document data on the success of ITI in 300 haemophilia A patients with newly developed or already existing FVIII-inhibitors (also patients who might potentially have failed in earlier ITIs), which will be treated with ITI - preferably high-dose based on individualized product selection, in order to improve management of this potentially devastating complication of haemophilia treatment. In order to investigate the role of in vitro tests on individual ITI success rate in patients undergoing ITI, the inhibitor plasma samples can be assayed against different FVIII concentrates using the following in vitro tests: Batch selection, Thrombin generation assay (TGA), Thrombin Generation Test (TGT) to monitor FVIII efficacy, Epitope mapping,IgG Subclasses specific for FVIII, Immunogenotyping.
CONDITIONS
Official Title
A Survey on the Success of Inhibitor Elimination Using Individualized Concentrate Selection and Controlled ITI
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male patients of any age with severe (FVIII activity < 1%), moderate (FVIII activity >1% - 5%), or mild (FVIII activity > 5%) haemophilia A
- Presence of relevant inhibitor levels (> 0.6 BU) or reduced recovery or half-life of FVIII if inhibitor levels are below 0.6 BU
- Patients who failed an earlier ITI attempt are eligible
You will not qualify if you...
- Female
AI-Screening
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Trial Site Locations
Total: 1 location
1
Haemophilia Centre Rhine Main
Frankfurt am Main, Hesse, Germany, 60596
Actively Recruiting
Research Team
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
0
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