A Survey on the Success of Inhibitor Elimination Using Individualized Concentrate Selection and Controlled ITI

Launched by HAEMOPHILIA CENTRE RHINE MAIN · Aug 1, 2014

Keywords

ClinConnect Summary

This clinical trial is looking at a treatment approach for men with Haemophilia A who have developed FVIII inhibitors, which are proteins that can make standard treatments less effective. The trial will involve around 300 male patients, including those who may not have had success with previous treatments. Researchers want to see if a personalized treatment plan, using specific doses and types of FVIII concentrates, can help improve the effectiveness of a treatment called Immune Tolerance Induction (ITI). This method aims to train the body to tolerate FVIII, ultimately making it easier to manage bleeding episodes.

To participate, men of any age with severe, moderate, or mild Haemophilia A and certain levels of inhibitors will be included. Those who have previously struggled with ITI are also welcome to join. Participants will undergo various tests to help assess how well the treatment is working and to find the most effective types of FVIII concentrates for their needs. This trial is currently recruiting participants, and it offers an opportunity to contribute to research that could improve the management of this challenging condition.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • Female