Studies how well inhibitor removal works in people with haemophilia A
Observes whether tailored high-dose immune tolerance treatment removes inhibitors in haemophilia A patients.
Plain-language title generated from the registry record
Registry title: A Survey on the Success of Inhibitor Elimination Using Individualized Concentrate Selection and Controlled ITI
Key facts
- Where
- Frankfurt am Main, GermanySee the site
Where in Germany
- Haemophilia Centre Rhine MainFrankfurt am Main, GermanyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Haemophilia Centre Rhine Main
- Trial code
- NCT02207894
- Record updated
- 21 April 2026
- Original description
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.Read full original descriptionShow less
A Survey on the Success of Inhibitor Elimination Using Individualized Concentrate Selection and Controlled (High Dose) Immune Tolerance Induction (ITI)
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.
Inclusion: Based on the decision of the treating physicians in the participating centres, male patients at any age suffering from severe (FVIII activity < 1%), moderate (FVIII activity >1% - 5%), or mild (FVIII activity > 5%) haemophilia A will be included into this post marketing observation if relevant inhibitor levels (> 0.6 BU) have been detected, or - in case of an inhibitor level <0.6 BU - with reduced recovery or half-life of FVIII; The observation is also open for patients who failed an earlier ITI attempt.
Exclusion: Female.