Hunter Syndrome Clinical Trial
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
| NCT number | NCT05795361 |
| Other study ID # | TAK-609-5005 |
| Secondary ID | |
| Status | Available |
| Phase | |
| First received | |
| Last updated |
| Verified date | April 2024 |
| Source | Takeda |
| Contact | Takeda Contact |
| Phone | +1877-825-3327 |
| medinfoUS[@]takeda.com | |
| Is FDA regulated | No |
| Health authority | |
| Study type | Expanded Access |
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.
| Status | Available |
| Enrollment | 0 |
| Est. completion date | |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Male |
| Age group | N/A and older |
| Eligibility | Inclusion Criteria: 1. 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. 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: 1. Participant has a condition that in the opinion of the treating physician may compromise their safety. 2. Participant has a known hypersensitivity to idursulfase-IT or its components. |
| Country | Name | City | State |
|---|---|---|---|
| Australia | Queensland Childrens Hospital | South Brisbane | Queensland |
| Mexico | Instituto Nacional de Pediatria | Coyoacan | Ciudad De Mexico |
| Mexico | H.C.U. de Valladolid | Valladolid | |
| Spain | Hospital Universitario Reina Sofia | Cordoba | |
| Spain | Hospital 12 de Octubre | Usera | Madrid |
| United Kingdom | Birmingham Womens and ChildrensNHS Foundation Trust | Birmingham | |
| United Kingdom | Universtity College London Hospital | London | |
| United Kingdom | Royal Manchester Children's Hospital - PPDS | Manchester | |
| United States | Childrens Hospital Orange County | Anaheim | California |
| United States | Children's Hospital Colorado | Aurora | Colorado |
| United States | The University of North Carolina | Chapel Hill | North Carolina |
| United States | Ann and Robert H Lurie Childrens Hospital of Chicago | Chicago | Illinois |
| United States | The Cleveland Clinic Foundation | Cleveland | Ohio |
| United States | Texas Oncology P.A | Dallas | Texas |
| United States | Joseph M. Sanzari Children's Hospital | Hackensack | New Jersey |
| United States | Jackson Memorial Hospital University of Miami | Miami | Florida |
| United States | Vanderbilt Children's Hospital | Nashville | Tennessee |
| United States | NYU Langone Medical Center | New York | New York |
| United States | The Regents of the University of California | Oakland | California |
| United States | Board of Regents of the University of Nebraska | Omaha | Nebraska |
| United States | The Children's Hospital of Philadelphia | Philadelphia | Pennsylvania |
| United States | Phoenix Childrens Hospital | Phoenix | Arizona |
| United States | UPMC Childrens Hospital of Pittsburgh | Pittsburgh | Pennsylvania |
| United States | Randall Children's Hospital at Legacy Emanuel | Portland | Oregon |
| United States | Division of Medical Genetics, University of Utah | Salt Lake City | Utah |
| United States | Seattle Children's Hospital - PIN | Seattle | Washington |
| United States | Washington University | Washington | Missouri |
| United States | The Nemours Foundation | Wilmington | Delaware |
| Lead Sponsor | Collaborator |
|---|---|
| Takeda |
United States, Australia, Mexico, Spain, United Kingdom,
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