drugset / Trial / NCT02196207

Hemophilia Inhibitor Clinical Trials (INHIBIT) Platform

NCT02196207

Phase 3 Withdrawn Margaret Ragni
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

EvaluationDrugModalityDoseRoute
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

Indications