RecruitingNCT02207894

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

A Survey on the Success of Inhibitor Elimination Using Individualized Concentrate Selection and Controlled (High Dose) Immune Tolerance Induction (ITI)

Sponsor

Haemophilia Centre Rhine Main

Enrollment

300 participants

Start Date

Aug 1, 2006

Study Type

OBSERVATIONAL

Conditions

Haemophilia A

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 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.

Eligibility

Sex: MALE

Plain Language Summary

Simplified for easier understanding

This observational study tracks the outcomes of male patients with hemophilia A who have developed inhibitors — antibodies that block the effectiveness of factor VIII (the clotting protein they need). Researchers are studying whether individualized selection of clotting factor concentrate, combined with immune tolerance induction (ITI) therapy, can successfully eliminate these inhibitors. You may be eligible if: - You are male with severe, moderate, or mild hemophilia A - You have developed inhibitors at levels above 0.6 BU, or have reduced recovery or half-life of factor VIII with lower inhibitor levels - You may have previously attempted and failed ITI therapy - You are of any age You may NOT be eligible if: - You are female Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(1)

Haemophilia Centre Rhine Main

Frankfurt am Main, Hesse, Germany

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NCT02207894

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