Post-trial Access Program of Idursulfase-IT Along With Elaprase in Children With Hunter Syndrome
Part of paid clinical trials in Phoenix, Arizona.
- Sponsor
- Takeda
- Study ID
- NCT05795361
- Status
- Available
Conditions
- Hunter Syndrome
Eligibility Criteria
- Sex
- MALE
- Age
- N/A - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Idursulfase-IT — DRUGParticipants 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.
Study Details
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 Dates
- First listed
- Apr 3, 2023
- Status verified
- Apr 2026
Central Contacts
- Takeda Contact+1877-825-3327
Locations (17)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Phoenix Childrens Hospital | Phoenix | Arizona | 85015 | Site Contact Jasmine Knoll (PRINCIPAL_INVESTIGATOR) |
| The Regents of the University of California | Oakland | California | 94609 | Site Contact Paul Harmatz (PRINCIPAL_INVESTIGATOR) |
| The Nemours Foundation | Wilmington | Delaware | 19803 | Site Contact Jeffery Campbell (PRINCIPAL_INVESTIGATOR) |
| Jackson Memorial Hospital University of Miami | Miami | Florida | 33101 | Site Contact Willa Thorson (PRINCIPAL_INVESTIGATOR) |
| Ann and Robert H Lurie Childrens Hospital of Chicago | Chicago | Illinois | 60611 | Site Contact Barbara Burton (PRINCIPAL_INVESTIGATOR) |
| Washington University | Washington | Missouri | 63130 | Site Contact Dorothy Grange (PRINCIPAL_INVESTIGATOR) |
| Board of Regents of the University of Nebraska | Omaha | Nebraska | 68198-5450 | Site Contact William Rizzo (PRINCIPAL_INVESTIGATOR) |
| Joseph M. Sanzari Children's Hospital | Hackensack | New Jersey | 07601 | Site Contact Helio Pedro (PRINCIPAL_INVESTIGATOR) |
| NYU Langone Medical Center | New York | New York | 10017 | Site Contact Devorah Segal (PRINCIPAL_INVESTIGATOR) |
| The University of North Carolina | Chapel Hill | North Carolina | 27514 | Site Contact Joesph Muenzer (PRINCIPAL_INVESTIGATOR) |
| The Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | Site Contact Rabi Hanna (PRINCIPAL_INVESTIGATOR) |
| Randall Children's Hospital at Legacy Emanuel | Portland | Oregon | 97227 | Site Contact George Anadiotis (PRINCIPAL_INVESTIGATOR) |
| The Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | Site Contact Can Ficicioglu (PRINCIPAL_INVESTIGATOR) |
| UPMC Childrens Hospital of Pittsburgh | Pittsburgh | Pennsylvania | 15224 | Site Contact Damara Ortiz (PRINCIPAL_INVESTIGATOR) |
| Vanderbilt Children's Hospital | Nashville | Tennessee | 37232-7610 | Site Contact Neena Agrawal (PRINCIPAL_INVESTIGATOR) |
| Division of Medical Genetics, University of Utah | Salt Lake City | Utah | 84112 | Site Contact David Viskochil (PRINCIPAL_INVESTIGATOR) |
| Seattle Children's Hospital - PIN | Seattle | Washington | 98105 | Site Contact Emily Shelkowitz (PRINCIPAL_INVESTIGATOR) |
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