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)

Hemophilia A With Inhibitors Clinical Trial

Official title:
A Non-controlled, Open-Label, Multicenter, Study of Efficacy of rFVIIIFc for Immune Tolerance Induction (ITI) in Severe Hemophilia A Subjects With Inhibitors Undergoing the First ITI Treatment

Status Completed

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03093480
Study type	Interventional
Source	Sanofi
Contact
Status	Completed
Phase	Phase 4
Start date	December 8, 2017
Completion date	February 16, 2021

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See also
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Terminated	`NCT00212472` - International Immune Tolerance Study	N/A
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Completed	`NCT02448680` - A Phase III Study on the Safety, Pharmacokinetics and Efficacy of Coagulation Factor VIIa	Phase 3
Active, not recruiting	`NCT01105546` - rFVIIa Prophylaxis in Children With Hemophilia A and Inhibitors	Phase 2
Completed	`NCT02020369` - A Phase III Study on the Safety, Pharmacokinetics and Efficacy of Coagulation Factor VIIa (Recombinant) in Congenital Hemophilia A or B Patients With Inhibitors to Factor VIII or IX	Phase 3