Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
134 participants
INTERVENTIONAL
2002-07-31
2012-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
Low-dose treatment (50 FVIII u/kg three times a week).
Factor VIII concentrates
To be determined at the discretion of the investigator.
Low-dose treatment
50 FVIII u/kg three times a week.
2
High-dose treatment (200 FVIII u/kg per day).
Factor VIII concentrates
To be determined at the discretion of the investigator.
High-dose treatment
200 FVIII u/kg per day.
Interventions
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Factor VIII concentrates
To be determined at the discretion of the investigator.
Low-dose treatment
50 FVIII u/kg three times a week.
High-dose treatment
200 FVIII u/kg per day.
Eligibility Criteria
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Inclusion Criteria
* A maximum historical inhibitor titer of between 5 BU and 200 BU that must be confirmed once prior to the beginning of ITI.
* The inhibitor titer should be \<10 BU at the start of ITI, confirmed once.
* The inhibitor must be present for \<24 months when ITI begins.
* Maximum age of 7 at the start of ITI.
* Willingness to comply with the protocol.
Exclusion Criteria
* Spontaneous disappearance of the inhibitor prior to ITI.
* Historical maximum inhibitor titer \<5 BU or \> 200 BU before starting ITI.
* Inhibitor titer \> 10 BU at the start of ITI.
* Inhibitor present for more than 24 months before starting ITI.
* Systemic immunomodulatory drug therapy during immune tolerance e.g. corticosteroids (\< 5 days every 2 months maximum dose 2 mg/kg or 60 mg/day), azathioprine, cyclophosphamide, high-dose immunoglobulin or the use of a protein A column or plasmapheresis.
* Age \> 7 years at the start of ITI.
* Inability or unwillingness to comply with the protocol.
* Previous attempt at ITI.
7 Years
ALL
No
Sponsors
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Manchester University NHS Foundation Trust
OTHER_GOV
New York Presbyterian Hospital
OTHER
Responsible Party
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New York Presbyterian Hospital
Principal Investigators
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Donna M DiMichele, MD
Role: PRINCIPAL_INVESTIGATOR
Weill Cornell Medical College-NY Presybetrian Hospital
Charles Hay, MD
Role: PRINCIPAL_INVESTIGATOR
Manchester Royal Infirmary
Locations
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University of Alabama Birmingham Medical Center
Birmingham, Alabama, United States
City of Hope Medical Center
Duarte, California, United States
Children's Hospital of Orange County
Orange, California, United States
Mountain States Regional Hemophilia and Thrombosis Center
Aurora, Colorado, United States
All Children's Hospital
St. Petersburg, Florida, United States
Children's Healthcare of Atlanta
Atlanta, Georgia, United States
Rush Presbyterian St. Lukes
Chicago, Illinois, United States
Children's Memorial Hospital
Chicago, Illinois, United States
Comprehensive Bleeding Disorders Center
Peoria, Illinois, United States
Indiana Hemophilia & Thrombosis Center
Indianapolis, Indiana, United States
Tulane University Hospital and Clinic
New Orleans, Louisiana, United States
Maine Children's Cancer Program
Scarborough, Maine, United States
Tufts - New England Medical Center
Boston, Massachusetts, United States
Children's Hospital Boston
Boston, Massachusetts, United States
University of Michigan Health Hospitals
Ann Arbor, Michigan, United States
MSU Centers for Bleeding & Clotting Disorders
East Lansing, Michigan, United States
Children's Hospital Minneapolis
Minneapolis, Minnesota, United States
Mayo Comprehensive Hemophilia Center
Rochester, Minnesota, United States
Kansas City Regional Hemophilia Center-The Children's Mercy Hospital
Kansas City, Missouri, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Newark Beth Israel Medical Center
Newark, New Jersey, United States
Saint Michael's Medical Center
Newark, New Jersey, United States
Ted R. Montoya Hemophilia Treatment Center
Albuquerque, New Mexico, United States
NY Presbyterian Hospital
New York, New York, United States
Mount Sinai Medical Center
New York, New York, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Children's Hospital Medical Center of Akron
Akron, Ohio, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Columbus Children's Hospital
Columbus, Ohio, United States
Oregon Health and Science University
Portland, Oregon, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
St. Christopher's Hospital for Children, Section of Hem/Onc
Philadelphia, Pennsylvania, United States
The Hemophilia Center of Western Pennsylvania
Pittsburgh, Pennsylvania, United States
St. Jude Children's Research Hospital
Memphis, Tennessee, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
University of Texas Health Science Center-Gulf States Hemophilia & Thrombosis Center
Houston, Texas, United States
Children's Hospital of the King's Daughters
Norfolk, Virginia, United States
Naval Medical Center
Portsmouth, Virginia, United States
Comprehensive Center for Bleeding Disorders
Milwaukee, Wisconsin, United States
Countries
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Other Identifiers
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ITI
Identifier Type: -
Identifier Source: org_study_id