drugset / Trial / NCT04303559
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
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 |