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)



Status:Recruiting
Conditions:Hematology
Therapuetic Areas:Hematology
Healthy:No
Age Range:Any
Updated:4/5/2019
Start Date:June 30, 2017
End Date:November 2020
Contact:Bioverativ Therapeutics Inc, Waltham, MA, USA
Email:clinicaltrials@bioverativ.com
Phone:1-888-794-1415

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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

The primary purpose of this study is 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.


Inclusion Criteria:

- Ability of the participant or his legally authorized representative (e.g., parent or
legal guardian) to understand the purpose and risks of the study and provide signed
and dated informed consent and authorization to use protected health information in
accordance with national and local participant privacy regulations

- 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:

- Other coagulation disorder(s) in addition to hemophilia A

- 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
We found this trial at
17
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4650 Sunset Blvd
Los Angeles, California 90027
 (323) 660-2450
Childrens Hospital Los Angeles Children's Hospital Los Angeles is a 501(c)(3) nonprofit hospital for pediatric...
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Los Angeles, CA
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Miami, Florida 33124
(305) 284-2211
University of Miami A private research university with more than 15,000 students from around the...
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Miami, FL
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500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
University of Michigan The University of Michigan was founded in 1817 as one of the...
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Aurora, CO
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1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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Chicago, IL
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Dayton, Ohio 45404
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Dayton, OH
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3901 Beaubien St
Detroit, Michigan 48201
(313) 745-5437
Children's Hospital of Michigan Since 1886, the Children's Hospital of Michigan has been dedicated to...
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Detroit, MI
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East Lansing, Michigan 48824
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El Paso, Texas 79905
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El Paso, TX
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801 7th Avenue
Fort Worth, Texas 76104
(682) 885-4000
Cook Children's Medical Center Cook Children's Health Care System is a not-for-profit, nationally recognized pediatric...
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Fort Worth, TX
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Houston, TX
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Indianapolis, Indiana 46260
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Indianapolis, IN
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Iowa City, IA
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7731 Old Canton Road
Madison, Mississippi 39110
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Madison, MS
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1010 West La Veta Avenue
Orange, California 92868
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Orange, CA
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111 Michigan Ave NW
Washington, District of Columbia
(202) 476-5000
Childrens National Medical Center As the nation’s children’s hospital, the mission of Children’s National Medical...
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Washington,
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