Post-trial Access Program of Idursulfase-IT Along With Elaprase in Children With Hunter Syndrome
- Conditions
- Hunter Syndrome
- Registration Number
- NCT05795361
- Lead Sponsor
- Takeda
- Brief Summary
As the HGT-HIT-046 (NCT01506141) and SHP609-302 (NCT02412787) studies will be 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- AVAILABLE
- Sex
- Male
- Target Recruitment
- Not specified
- Participants will have completed the treatment period of the HGT-HIT-046 (NCT01506141) or SHP609-302 (NCT02412787) study prior to the first dose on this program.
- 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).
- Participant has a condition that in the opinion of the treating physician may compromise their safety.
- Participant has a known hypersensitivity to idursulfase-IT or its components.
Study & Design
- Study Type
- EXPANDED_ACCESS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (28)
Childrens Hospital Orange County
🇺🇸Anaheim, California, United States
The Children's Hospital of Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
The Regents of the University of California
🇺🇸Oakland, California, United States
Phoenix Childrens Hospital
🇺🇸Phoenix, Arizona, United States
The Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
UPMC Childrens Hospital of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States
Randall Children's Hospital at Legacy Emanuel
🇺🇸Portland, Oregon, United States
Children's Hospital Colorado
🇺🇸Aurora, Colorado, United States
The Nemours Foundation
🇺🇸Wilmington, Delaware, United States
Washington University
🇺🇸Washington, Missouri, United States
The University of North Carolina
🇺🇸Chapel Hill, North Carolina, 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
Board of Regents of the University of Nebraska
🇺🇸Omaha, Nebraska, United States
NYU Langone Medical Center
🇺🇸New York, New York, United States
Joseph M. Sanzari Children's Hospital
🇺🇸Hackensack, New Jersey, United States
Royal Manchester Children's Hospital - PPDS
🇬🇧Manchester, United Kingdom
Vanderbilt Children's Hospital
🇺🇸Nashville, Tennessee, United States
Texas Oncology P.A
🇺🇸Dallas, Texas, United States
Birmingham Womens and ChildrensNHS Foundation Trust
🇬🇧Birmingham, United Kingdom
Universtity College London Hospital
🇬🇧London, United Kingdom
Division of Medical Genetics, University of Utah
🇺🇸Salt Lake City, Utah, United States
Seattle Children's Hospital - PIN
🇺🇸Seattle, Washington, United States
H.C.U. de Valladolid
🇲🇽Valladolid, Mexico
Queensland Childrens Hospital
🇦🇺South Brisbane, Queensland, Australia
Instituto Nacional de Pediatria
🇲🇽Coyoacan, Ciudad De Mexico, Mexico
Hospital 12 de Octubre
🇪🇸Usera, Madrid, Spain
Hospital Universitario Reina Sofia
🇪🇸Cordoba, Spain