CompletedNot Applicable

Rescue Immunotolerance Study in Induction of Immune Tolerance (ITI)-Experienced Patients (RES.I.S.T. Experienced)

United States3 participantsStarted 2009-11-03

Plain-language summary

The purpose of this study is to evaluate whether a concentrate containing both FVIII and von Willebrand Factor (VWF) given at a high dose will induce immune tolerance in subjects who have already experienced and failed ITI with VWF-free FVIII concentrates. The treatment on this study is expected to last up to 33 months.

Who can participate

SexMALE

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Inclusion criteria

✓. severe hemophilia A (FVIII\<1%) with high responding inhibitors (peak levels \>5 BU)
✓. male, any age;
✓. any inhibitor level at study enrollment;
✓. ability and willingness to participate to the study;
✓. previous ITI course of at least 9 months with a VWF-free FVIII concentrate at any dosage, such as recombinant FVIII and/or monoclonally purified FVIII.

Exclusion criteria

✕. concomitant systemic treatment with immunosuppressive drugs;
✕. concomitant experimental treatment;
✕. previous history of myocardial infarction and/or cerebral stroke

What they're measuring

Achievement of an inhibitor titer of <0.6 BU/failure to achieve an inhibitor titer of <0.6 BU within 33 months, or failure to decrease inhibitor titer by at least 20% compared to titer in prior 6 months, beginning at 3 months after starting ITI

Timeframe: 3 years

Trial details

NCT IDNCT01051076

SponsorCity of Hope Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-10-21

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