The Hemophilia Inhibitor Prevention Trial

Phase 3 Terminated 1 enrolled Margaret Ragni Health Resources and Services Administration (HRSA) · collab

RandomizedParallel-groupOpen-labelPrevention

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.

Timeline

Start: 2021-10-11
Primary completion: 2022-04-06
Completion: 2022-06-16

Outcome

Outcome not reported

Stopped (Enrollment): “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.”

Publications

Background Ragni MV, George LA; Members of Working Group 1, the NHLBI State of the Science Workshop on factor VIII inhibitors: Generating a national blueprint for future research. The national blueprint for future factor VIII inhibitor clinical trials: NHLBI State of the Science (SOS) Workshop on factor VIII inhibitors. Haemophilia. 2019 Jul;25(4):581-589. doi: 10.1111/hae.13717.
Background Ebbert PT, Xavier F, Malec LM, Seaman CD, Ragni MV. Observational study of recombinant factor VIII-Fc, rFVIIIFc, in hemophilia A. Thromb Res. 2020 Nov;195:51-54. doi: 10.1016/j.thromres.2020.07.004. Epub 2020 Jul 5.
Background Bertolet M, Brooks MM, Ragni MV. The design of a Bayesian platform trial to prevent and eradicate inhibitors in patients with hemophilia. Blood Adv. 2020 Nov 10;4(21):5433-5441. doi: 10.1182/bloodadvances.2020002789.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Efmoroctocog Alfa	Protein / enzyme biologic	65 iu/kg	Intravenous
Subject	Emicizumab	Monoclonal antibody	1.5 mg/kg	Subcutaneous