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
Many people being treated for severe Hemophilia A have serious complications. Antibodies often form during treatment. Immune Tolerance Induction (ITI) uses regular infusions over a period of time. It can take from a few months to a few years. This program removes these antibodies and improves overall treatment. This research will study the effectiveness of ITI. We want to find the best ways to implement ITI to improve the treatment of people with severe Hemophilia A.

An optimal regimen for ITI has not been identified. Patients with Hemophilia A can have high rates of illness, mortality, and associated costs. We hope to learn if there are advantages of using a patient-specific laboratory test called batch-selection. This may decrease the time to success in Immune Tolerance Induction (ITI).

Patients will be randomized on a one-to-one basis between one of two study arms. Patients will either be assigned to matched lot selection or random lot selection (current clinical practice in ITI). The purpose of this study is to compare the time to achieve negative inhibitor (<0.6 BU) between matched lot selection to random lot selection.
This study requires

  • Monthly evaluations (every other evaluation is in-person. 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
BENEFITS:

This study cannot promise any direct benefit to you or others. The results of this study may help us learn more about your condition. It may help patients in the future with the same condition as you.


RISKS:
Risks include allergic reaction and blood draw-related risks. Examples include pain, lightheadedness, bruising, discomfort, bleeding, swelling, and infection at the injection site. The study doctor will discuss the risks associated with taking part in this research study.
Compensation
You will not be compensated for taking part in this study.
Resources
PDF Docs
INITIATE Study Flyer
UC Davis IRB: 988465
ClinicalTrials.gov: NCT03204539
Schedule
Study duration and period
You will be in the study for up to 30 months, depending on the effectiveness of the treatment.
Recruitment period
From March 1, 2017 to March 31, 2022
Locations
UC Davis Medical Center
2315 Stockton Boulevard
Sacramento, CA 95817
Tulane Medical Center
1415 Tulane Avenue
New Orleans, LA 70112
Rush University Medical Center
1653 Ida B. Wells Drive
Chicago, IL 60612
Rady Children's Hospital San Diego
3020 Children's Way
San Diego, CA 92123
Contact
Katrina Wheeler

Have any questions or want to learn more? Leave your contact details below and the research team will reach out to you.


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