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Post-trial Access Program of Idursulfase-IT Along With Elaprase in Children With Hunter Syndrome
Sponsor: Takeda
Summary
As the HGT-HIT-046 (NCT01506141) and SHP609-302 (NCT02412787) studies are completed and closed, this post-trial access (PTA) program provides TAK-609 to participants in these studies for whom the benefit:risk ratio of continued treatment with idursulfase-IT remains positive.
Official title: Post-trial Access Program: Idursulfase-IT (HGT-2310) in Conjunction With Intravenous Elaprase® in Pediatric and Adult Patients With Hunter Syndrome and Cognitive Impairment
Key Details
Gender
MALE
Age Range
Any - Any
Study Type
EXPANDED_ACCESS
Enrollment
Not specified
Start Date
Not specified
Completion Date
Not specified
Last Updated
2026-04-13
Healthy Volunteers
No
Conditions
Interventions
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.
Locations (22)
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