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)

PHASE4CompletedINTERVENTIONAL
Enrollment

16

Participants

Timeline

Start Date

December 8, 2017

Primary Completion Date

May 4, 2020

Study Completion Date

February 16, 2021

Conditions
Hemophilia A With Inhibitors
Interventions
BIOLOGICAL

rFVIIIFc

rFVIIIFc 200 IU/kg/day in ITI Period, 50 or 100 IU/kg (adjusted according to Investigator judgement) in tapering Period, and prophylactic regimen in Follow-Up period as powder for injection administered intravenously.

Trial Locations (37)

1200

Cliniques Universitaires Saint-Luc, Brussels

1527

UMHAT 'Tsaritsa Yoanna - ISUL', EAD, Sofia

3000

UZ Leuven, Leuven

4000

"UMHAT Sv. Georgi, EAD", Plovdiv

8035

Hospital Universitari Vall d'Hebron, Barcelona

13385

Hôpital de la Timone, Marseille

20010

Children's National Medical Center, Washington D.C.

20122

Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico, Milan

25030

CHU Besançon - Hôpital Jean Minjoz, Besançon

28046

Hospital Universitario La Paz, Madrid

31059

CHU de Toulouse - Hôpital Purpan, Toulouse

36100

Ospedale San Bortolo di Vicenza, Vicenza

45404

Dayton Children's Hospital, Dayton

46026

Hospital Universitari i Politecnic La Fe, Valencia

46260

Indiana Hemophilia and Thrombosis Center, Indianapolis

48201

Childrens Hospital of Michigan, Detroit

52242

University of Iowa Children's Hospital, Iowa City

53127

Universitaetsklinikum Bonn AoeR, Bonn

53226

Blood Center of Southeast Wisconsin, Milwaukee

59037

Hemostase Clinique - Institut Cœur-Poumons (4eme étage aile est), Lille

60612

Rush University Medical Center, Chicago

75015

Hôpital Necker - Enfants Malades, Paris

76104

Cook Children's Medical Center, Fort Worth

77030

Gulf States Hemophilia and Thrombophilia Center, Houston

79905

El Paso Children's Hospital, El Paso

80045

University of Colorado Hemophilia & Thrombosis Center, Aurora

80122

Azienda Ospedaliera Pediatrica Santobono Pausillipon, Napoli

92868

Center for Inherited Blood Disorders, Orange

V6H 3N1

Children's & Women's Health Centre of British Columbia, Vancouver

L8N 3Z5

McMaster Children's Hospital, Hamilton

M5G 1X8

The Hospital for Sick Children, Toronto

466-8550

Nagoya University Hospital, Nagoya

216-8511

St. Marianna University School of Medicine Hospital, Kawasaki

634-8521

Nara Medical University Hospital, Kashihara-shi

SE1 7EH

St Thomas' Hospital, London

OX3 9DU

John Radcliffe Hospital, Oxford

G514TF

Royal Hospital for Children, Glasgow

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Swedish Orphan Biovitrum

INDUSTRY

lead

Bioverativ, a Sanofi company

INDUSTRY