The INITIATE Research Study for people with Hemophilia A and inhibitors to Factor VIII

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"Help us learn about a patient-specific lab test to decrease time to success of Immune Tolerance Induction"
Age:
0-80
Gender:
Male
Healthy Volunteers:
No
Keywords:
Hemophilia A, Inhibitors, Bleeding, Antibodies, WILATE, Factor VIII, Factor 8, Concentrate, Immune Tolerance, Immune Tolerance Induction
Type:
Phase IV, double-blind randomized
Target:
120 Participants
Investigator:
Description
We hope to learn through this study if there are potential advantages of using a patient-specific laboratory test called batch-selection to decrease the time to success in Immune Tolerance Induction (ITI) for hemophilia A patients with inhibitors to Factor VIII.

Immune Tolerance Induction (ITI) is a treatment that consists of repeated infusions of factor concentrate over a period of time with a goal to train the body to tolerate the factor concentrate.
This study requires
• Monthly evaluations (every other evaluation is in-person and alternating evaluations may be over the phone)
• Monthly lab tests
• Daily infusion of WILATE® factor VIII concentrate from home for at least 6 months
• Completion of a study diary for every bleeding event
Who can participate?
• Patients diagnosed with inherited Hemophilia A
• Factor VIII activity ≤2%
• History of high levels of inhibitors to Factor VIII
Benefits and risks of participating
There is no direct benefit. The results of this study may help us learn if there are potential advantages of utilizing a patient-specific laboratory test called batch-selection to decrease the time to success in Immune Tolerance Induction (ITI) for hemophilia A patients with inhibitors to FVIII.

Risks include allergic reaction and blood draw-related risks such as pain, lightheadedness, bruising, discomfort, bleeding, swelling, and infection at the injection site.
Resources
PDF Docs
INITIATE Study Flyer
Schedule
Study duration and period
Research participation is up to 30 months depending on the effectiveness of the treatment.
Recruitment period
From March 1, 2017 to March 31, 2022
Contact
Katrina Wheeler

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