Status:
TERMINATED
The Hemophilia Inhibitor Eradication Trial
Lead Sponsor:
Margaret Ragni
Collaborating Sponsors:
Health Resources and Services Administration (HRSA)
Conditions:
Hemophilia A With Inhibitor
Eligibility:
MALE
Phase:
PHASE3
Brief Summary
This is a multi-center randomized phase III clinical trial, the Inhibitor Eradication Trial, in which Eloctate ITI plus Emicizumab will be compared with Eloctate ITI alone to eradicate inhibitors in s...
Detailed Description
This is a multi-center randomized phase III clinical trial, the Inhibitor Eradication Trial, in which Eloctate ITI plus Emicizumab will be compared with Eloctate ITI alone to eradicate inhibitors in p...
Eligibility Criteria
Inclusion
- Male adults or children \> 4 months of age.
- Severe hemophilia A (FVIII \< 0.01 U/ml).
- Current or past high-responding inhibitor, anti-FVIII \>= 5.0 B.U., ITI-refractory or ITI-naive.
Exclusion
- Acquired hemophilia or any bleeding disorder other than hemophilia A.
- Current use of Emicizumab, or if used, \> 8 weeks since last treatment.
- Use of an experimental drug(s).
- Surgery anticipated in the next 48 weeks.
- Life expectancy less than 5 years.
- Patient/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, 8, 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 :
November 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 27 2022
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT04303572
Start Date
November 1 2021
End Date
June 27 2022
Last Update
February 21 2023
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Hemophilia Center of Western PA
Pittsburgh, Pennsylvania, United States, 15213
2
University of Pittsburgh and Hemophilia Center Western PA
Pittsburgh, Pennsylvania, United States, 15213