drugset / Trial / NCT02196207
Hemophilia Inhibitor Clinical Trials (INHIBIT) Platform
RandomizedParallel-groupOpen-labelTreatment
Summary
This study will evaluate if Eloctate is superior to Emicizumab in reducing inhibitors in children with severe hemophilia when given before the first bleed (preemptive) and continued weekly to prevent bleeds (prophylaxis); and whether Eloctate immune tolerance induction (ITI) plus emicizumab is superior to Eloctate ITI alone in eradicating inhibitor formation in children and adults with severe hemophilia A.
Timeline
- Start
- 2020-08
- Primary completion
- 2027-07
- Completion
- 2027-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Efmoroctocog Alfa | Protein / enzyme biologic | 65 iu/kg | Intravenous |
| Subject | Efmoroctocog Alfa | Protein / enzyme biologic | 100 iu/kg | Intravenous |
| Subject | Emicizumab | Monoclonal antibody | 1.5 mg/kg | Subcutaneous |