Status:
TERMINATED
The Hemophilia Inhibitor Prevention Trial
Lead Sponsor:
Margaret Ragni
Collaborating Sponsors:
Health Resources and Services Administration (HRSA)
Conditions:
Hemophilia A Without Inhibitor
Eligibility:
MALE
4-4 years
Phase:
PHASE3
Brief Summary
This is a multi-center randomized phase III clinical trial, the Inhibitor Prevention Trial, in which Eloctate will be compared with Emicizumab, using adaptive design, to prevent inhibitors in patients...
Detailed Description
This is a multi-center randomized phase III clinical trial, the Inhibitor Prevention Trial, in which consecutive hemostatic agents will be compared using adaptive design to prevent inhibitors in patie...
Eligibility Criteria
Inclusion
- Male children \>= 4 months and up to 4 years of age.
- Severe hemophilia A (FVIII \< 0.01 U/ml).
- No evidence of an inhibitor i.e. anti-FVIII \< 0.6 B.U.
- No more than 3 FVIII exposures (Factor VIII concentrate, cryoprecipitate, or fresh frozen plasma), including circumcision.
Exclusion
- Acquired hemophilia or any bleeding disorder other than hemophilia A.
- Treatment with clotting factor or emicizumab previously.
- Use of an experimental drug(s).
- Surgery anticipated in the next 48 weeks.
- Life expectancy less than 5 years.
- Parent/caretaker unable or unwilling to keep a personal diary of bleeding frequency and study drug treatment, make monthly visits and blood draws at weeks 4, 12, 24, 36, and 48.
- Other illness, condition or reason in the opinion of the investigator that would make the patient unsuitable for the trial.
Key Trial Info
Start Date :
October 11 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 16 2022
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT04303559
Start Date
October 11 2021
End Date
June 16 2022
Last Update
April 11 2023
Active Locations (3)
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1
University of Arkansas Medical Sciences Childrens Hospital
Little Rock, Arkansas, United States, 72202
2
Hemophilia Center of Western PA
Pittsburgh, Pennsylvania, United States, 15213
3
University of Pittsburgh and Hemophilia Center Western PA
Pittsburgh, Pennsylvania, United States, 15213