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Post-trial Access Program: Idursulfase-IT (HGT-2310) in Conjunction With Intravenous Elaprase® in Pediatric and Adult Patients With Hunter Syndrome and Cognitive Impairment
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.
Age
All ages
Sex
MALE
Healthy Volunteers
No
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
Last Updated
April 22, 2025
Idursulfase-IT
DRUG
Lead Sponsor
Takeda
NCT05422482
NCT02412787
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT01372228