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)
NCT ID: NCT03093480
Last Updated: 2022-03-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
16 participants
INTERVENTIONAL
2017-12-08
2021-02-16
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Recombinant coagulation factor VIII Fc (rFVIIIFc)
Participants were to receive rFVIIIFc at a dose of 200 international units (IU)/kilogram (kg) as once daily injections or divided on several injections per day at the discretion of the Investigator, starting at baseline visit up to maximum of 48 Weeks in ITI Period. Participants who met the criteria for immune tolerance induction (ITI) success entered the tapering period and received rFVIIIFc at a dose adjusted according to Investigator judgment based on the FVIII activity levels and with the aim of tapering the rFVIIIFc dose to reach a prophylactic dosing regimen within 16 weeks (4 months). Follow-Up was for 32 weeks under an adjusted prophylactic regimen according to Investigator judgment.
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Male participants of any age diagnosed with severe hemophilia A (as confirmed from the medical record)
* Currently diagnosed with high titer inhibitors (historical peak greater than or equal to (\>=) 5 Bethesda units per milliliter (BU/mL), according to medical records)
* Previously treated with any plasma-derived or recombinant conventional or Extended Half-Life FVIII
Exclusion Criteria
* Previous immune tolerance induction (ITI)
* History of hypersensitivity or anaphylaxis associated with any factor VIII (FVIII) administration
* Planned major surgery scheduled during the study unless deferred until after study completion (minor surgery such as tooth extraction or insertion/replacement of central venous access device is allowed)
* Abnormal renal function (serum creatinine \>1.5 milligram per deciliter (mg/dL) or 2 × upper limit of normal (ULN) for participant age based on local laboratory range) as assessed by local laboratory
* Serum alanine aminotransferase or aspartate aminotransferase \> 5 × upper limit of normal (ULN) as assessed by local laboratory
MALE
No
Sponsors
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Swedish Orphan Biovitrum
INDUSTRY
Bioverativ, a Sanofi company
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Sciences & Operations
Role: STUDY_DIRECTOR
Sanofi
Locations
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Center for Inherited Blood Disorders
Orange, California, United States
University of Colorado Hemophilia & Thrombosis Center
Aurora, Colorado, United States
Children's National Medical Center
Washington D.C., District of Columbia, United States
Rush University Medical Center
Chicago, Illinois, United States
Indiana Hemophilia and Thrombosis Center
Indianapolis, Indiana, United States
University of Iowa Children's Hospital
Iowa City, Iowa, United States
Childrens Hospital of Michigan
Detroit, Michigan, United States
Dayton Children's Hospital
Dayton, Ohio, United States
El Paso Children's Hospital
El Paso, Texas, United States
Cook Children's Medical Center
Fort Worth, Texas, United States
Gulf States Hemophilia and Thrombophilia Center
Houston, Texas, United States
Blood Center of Southeast Wisconsin
Milwaukee, Wisconsin, United States
Cliniques Universitaires Saint-Luc
Brussels, , Belgium
UZ Leuven
Leuven, , Belgium
UMHAT "Sv. Georgi", EAD
Plovdiv, , Bulgaria
UMHAT 'Tsaritsa Yoanna - ISUL', EAD
Sofia, , Bulgaria
Children's & Women's Health Centre of British Columbia
Vancouver, British Columbia, Canada
McMaster Children's Hospital
Hamilton, Ontario, Canada
The Hospital for Sick Children
Toronto, Ontario, Canada
Hôpital de la Timone
Marseille, Bouches-Du-Rhône, France
CHU Besançon - Hôpital Jean Minjoz
Besançon, Doubs, France
CHU de Toulouse - Hôpital Purpan
Toulouse, Haute Garonne, France
Hemostase Clinique - Institut Cœur-Poumons (4eme étage aile est)
Lille, Nord, France
Hôpital Necker - Enfants Malades
Paris, , France
Universitaetsklinikum Bonn AoeR
Bonn, North Rhine-Westphalia, Germany
Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico
Milan, , Italy
Azienda Ospedaliera Pediatrica Santobono Pausillipon
Napoli, , Italy
Ospedale San Bortolo di Vicenza
Vicenza, , Italy
Nagoya University Hospital
Nagoya, Aichi-ken, Japan
St. Marianna University School of Medicine Hospital
Kawasaki, Kanagawa, Japan
Nara Medical University Hospital
Kashihara-shi, Nara, Japan
Hospital Universitari Vall d'Hebron
Barcelona, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Hospital Universitari i Politecnic La Fe
Valencia, , Spain
St Thomas' Hospital
London, Greater London, United Kingdom
John Radcliffe Hospital
Oxford, Oxfordshire, United Kingdom
Royal Hospital for Children
Glasgow, Strathclyde, United Kingdom
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2017-000373-36
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
997HA402
Identifier Type: OTHER
Identifier Source: secondary_id
LPS16473
Identifier Type: -
Identifier Source: org_study_id
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