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

Completed · Not applicable

Conditions studied: Severe Hemophilia A

In brief

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.

Key facts

Study ID

NCT01051076

Run by

City of Hope Medical Center

People needed

3

Starts

2009-11-03

Expected to finish

2020-10-21

Last updated by the study team

2021-08-23

Who can join

Age: any. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

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

Where it is running

• City of Hope Medical Center — Duarte, California, United States

Full record on ClinicalTrials.gov

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