A Study to Evaluate Efficacy of rFVIIIFc for Immune Tolerance Induction (ITI) in Severe Hemophilia A Participants With Inhibitors Undergoing the First ITI Treatment (verITI-8 Study)

Phase 4 Completed 16 enrolled Bioverativ, a Sanofi company Swedish Orphan Biovitrum · collab

NaSingle-groupOpen-labelTreatment

Summary

The primary purpose of this study was to describe the time to tolerization (i.e., ITI success) with rFVIIIFc in participants within a maximum of 48 weeks (12 months) of ITI treatment.

Timeline

Start: 2017-12-08
Primary completion: 2020-05-04
Completion: 2021-02-16

Publications

Malec L, Van Damme A, Chan AKC, Spasova M, Jain N, Sensinger C, Dumont J, Lethagen S, Carcao M, Peyvandi F. Recombinant factor VIII Fc fusion protein for first-time immune tolerance induction: final results of the verITI-8 study. Blood. 2023 Apr 20;141(16):1982-1989. doi: 10.1182/blood.2022017780.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Efmoroctocog Alfa	Protein / enzyme biologic	200 iu/kg	Intravenous

A Study to Evaluate Efficacy of rFVIIIFc for Immune Tolerance Induction (ITI) in Severe Hemophilia A Participants With Inhibitors Undergoing the First ITI Treatment (verITI-8 Study)

Summary

Timeline

Publications

Drugs

Indications