Post-trial Access Program of Idursulfase-IT Along With Elaprase in Children With Hunter Syndrome

Available (expanded access)

Conditions studied: Hunter Syndrome

In brief

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.

Key facts

Study ID

NCT05795361

Run by

Takeda

Last updated by the study team

2026-04-13

Who can join

Age: any. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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