The Hemophilia Inhibitor Eradication Trial

Stopped early · Phase 3

Conditions studied: Hemophilia A With Inhibitor

In brief

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.

Key facts

Study ID

NCT04303572

Run by

Margaret Ragni

People needed

1

Starts

2021-11-01

Expected to finish

2022-06-27

Last updated by the study team

2023-02-21

Who can join

Age: any. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Hemophilia Center of Western PA — Pittsburgh, Pennsylvania, United States
• University of Pittsburgh and Hemophilia Center Western PA — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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