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 |
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.
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
sites
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Childrens Hospital Los Angeles Children's Hospital Los Angeles is a 501(c)(3) nonprofit hospital for pediatric...
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University of Miami A private research university with more than 15,000 students from around the...
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University of Michigan The University of Michigan was founded in 1817 as one of the...
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Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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Children's Hospital of Michigan Since 1886, the Children's Hospital of Michigan has been dedicated to...
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Cook Children's Medical Center Cook Children's Health Care System is a not-for-profit, nationally recognized pediatric...
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111 Michigan Ave NW
Washington, District of Columbia
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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