Trial intelligence / Profile preview

Eloctate ITI plus Emicizumab for Inhibitor Eradication in Hemophilia A

NCT04303572Phase 3

Key facts

Status: Terminated
Start: Nov 2021
Primary completion: Jun 2022
Countries: 1
Modality: Bispecific Antibodies, Monoclonal Antibodies

Drugs: emicizumab
Conditions: hemophilia A

Overview

Phase 3, randomised, open-label trial of emicizumab in hemophilia A (2 arms). Primary endpoint: Inhibitor Eradication at 48 weeks. Started Nov 2021; status: terminated.

Design

2 arms

Study design: RandomizedOpen-label

Eloctate ITI plus Emicizumab
Eloctate 100 IU/kg every other day + Emicizumab (induction then maintenance)
Eloctate ITI
Eloctate 100 IU/kg every other day

Who it enrols

Male adults or children > 4 months with severe hemophilia A and high-responding inhibitors (>= 5.0 B.U.), ITI-refractory or ITI-naive.

Endpoints

Primary

Inhibitor Eradication48 weeks

Secondary

Number of Bleeding Events48 weeks
FVIII Trough Level48 weeks
Human Leukocyte Antigen (HLA) Haplotype48 weeks
FVIII Mutation48 weeks

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