Post-trial Access Program of Idursulfase-IT Along With Elaprase in Children With Hunter Syndrome
NCT ID: NCT05795361
Last Updated: 2025-04-22
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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AVAILABLE
EXPANDED_ACCESS
Brief Summary
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Detailed Description
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Conditions
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Interventions
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Idursulfase-IT
Participants will continue to receive the same dose of idursulfase-IT, once monthly, that was administered during the HGT-HIT-046 \[NCT01506141\] or SHP609-302 \[NCT02412787\] study \[10mg or 30mg\] along with intravenous (IV) infusions of standard-of-care therapy Elaprase via intrathecal drug delivery device (IDDD) or lumbar punctures.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Participant and/or a parent(s)/legal guardian is informed of the nature of this compassionate post-trial access program and can provide written informed consent for themselves or the child to participate (with assent from the child when appropriate prior to treatment).
Exclusion Criteria
2. Participant has a known hypersensitivity to idursulfase-IT or its components.
MALE
No
Sponsors
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Takeda
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
Takeda
Locations
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Phoenix Childrens Hospital
Phoenix, Arizona, United States
The Regents of the University of California
Oakland, California, United States
The Nemours Foundation
Wilmington, Delaware, United States
Jackson Memorial Hospital University of Miami
Miami, Florida, United States
Ann and Robert H Lurie Childrens Hospital of Chicago
Chicago, Illinois, United States
Washington University
Washington, Missouri, United States
Board of Regents of the University of Nebraska
Omaha, Nebraska, United States
Joseph M. Sanzari Children's Hospital
Hackensack, New Jersey, United States
NYU Langone Medical Center
New York, New York, United States
The University of North Carolina
Chapel Hill, North Carolina, United States
The Cleveland Clinic Foundation
Cleveland, Ohio, United States
Randall Children's Hospital at Legacy Emanuel
Portland, Oregon, United States
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
UPMC Childrens Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States
Vanderbilt Children's Hospital
Nashville, Tennessee, United States
Division of Medical Genetics, University of Utah
Salt Lake City, Utah, United States
Seattle Children's Hospital - PIN
Seattle, Washington, United States
Queensland Childrens Hospital
South Brisbane, Queensland, Australia
Instituto Nacional de Pediatria
Coyoacán, Mexico City, Mexico
H.C.U. de Valladolid
Valladolid, , Mexico
Hospital Universitario Reina Sofia
Córdoba, , Spain
Royal Manchester Children's Hospital - PPDS
Manchester, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Related Links
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To obtain more information on the study, click here/on this link
Other Identifiers
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TAK-609-5005
Identifier Type: -
Identifier Source: org_study_id
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