The Hemophilia Inhibitor Eradication Trial

• Status: Recruiting
• Trial end date: 2027-08-01
• Target enrollment: 0
• Participant gender: Male

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 severe hemophilia A.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Margaret Ragni
• Collaborator: Health Resources and Services Administration (HRSA)
• Treatments: Antibodies, Bispecific; Factor VIII

Criteria

Inclusion Criteria:

1. Male adults or children > 4 months of age.

2. Severe hemophilia A (FVIII < 0.01 U/ml).

3. Current or past high-responding inhibitor, anti-FVIII >= 5.0 B.U., ITI-refractory or ITI-naive.

Exclusion Criteria:

1. Acquired hemophilia or any bleeding disorder other than hemophilia A.

2. Current use of Emicizumab, or if used, > 8 weeks since last treatment.

3. Use of an experimental drug(s).

4. Surgery anticipated in the next 48 weeks.

5. Life expectancy less than 5 years.

6. 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.

7. Other illness, condition, or reason in the opinion of the investigator that would make the patient unsuitable for the trial.