TerminatedPhase 3

The Hemophilia Inhibitor Prevention Trial

Stopped: The INHIBIT Trials IDSMB, in a letter dated 05-18-22, recommended, given the slow enrollment, that the INHIBIT Trials be discontinued due to futility.

United States1 participantsStarted 2021-10-11

Plain-language 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 with severe hemophilia A.

Who can participate

Age range4 Months – 4 Years

SexMALE

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Inclusion criteria

✓. 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 criteria

✕. 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.

What they're measuring

Inhibitor Formation

Timeframe: 48 weeks

Trial details

NCT IDNCT04303559

SponsorMargaret Ragni

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-04-06

Results submitted2023-01-17

View on ClinicalTrials.gov More Hemophilia A Without Inhibitor trials