Status:
RECRUITING
A Survey on the Success of Inhibitor Elimination Using Individualized Concentrate Selection and Controlled ITI
Lead Sponsor:
Haemophilia Centre Rhine Main
Collaborating Sponsors:
University of Bonn
Skane University Hospital
Conditions:
Haemophilia A
Eligibility:
MALE
Brief Summary
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 ...
Detailed Description
As a result of many technological advances in the last two decades, current factor VIII (FVIII) concentrates (both plasma-derived and recombinant products) are considered very safe in terms of pathoge...
Eligibility Criteria
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
Key Trial Info
Start Date :
August 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT02207894
Start Date
August 1 2006
End Date
December 1 2027
Last Update
December 19 2024
Active Locations (1)
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1
Haemophilia Centre Rhine Main
Frankfurt am Main, Hesse, Germany, 60596