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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Idursulfase-IT | Drug | Participants 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Takeda Contact | Contact | +1877-825-3327 | medinfoUS@takeda.com |
| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phoenix Childrens Hospital | Available | Phoenix | Arizona | 85015 | United States |
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| Label | URL |
|---|---|
| To obtain more information on the study, click here/on this link | View source |
| Click here to ask Takeda's chatbot for comprehensive and easy-to-understand information about clinical trials - even across products and indications - in your local language. | View source |
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| The Regents of the University of California | Available | Oakland | California | 94609 | United States |
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| The Nemours Foundation | Available | Wilmington | Delaware | 19803 | United States |
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| Jackson Memorial Hospital University of Miami | Available | Miami | Florida | 33101 | United States |
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| Ann and Robert H Lurie Childrens Hospital of Chicago | Available | Chicago | Illinois | 60611 | United States |
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| Washington University | Available | Washington | Missouri | 63130 | United States |
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| Board of Regents of the University of Nebraska | Available | Omaha | Nebraska | 68198-5450 | United States |
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| Joseph M. Sanzari Children's Hospital | Available | Hackensack | New Jersey | 07601 | United States |
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| NYU Langone Medical Center | Available | New York | New York | 10017 | United States |
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| The University of North Carolina | Available | Chapel Hill | North Carolina | 27514 | United States |
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| The Cleveland Clinic Foundation | Available | Cleveland | Ohio | 44195 | United States |
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| Randall Children's Hospital at Legacy Emanuel | Available | Portland | Oregon | 97227 | United States |
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| The Children's Hospital of Philadelphia | Available | Philadelphia | Pennsylvania | 19104 | United States |
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| UPMC Childrens Hospital of Pittsburgh | Available | Pittsburgh | Pennsylvania | 15224 | United States |
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| Vanderbilt Children's Hospital | Available | Nashville | Tennessee | 37232-7610 | United States |
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| Division of Medical Genetics, University of Utah | Available | Salt Lake City | Utah | 84112 | United States |
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| Seattle Children's Hospital - PIN | Available | Seattle | Washington | 98105 | United States |
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| Queensland Childrens Hospital | Available | South Brisbane | Queensland | QLD 4101 | Australia |
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| Instituto Nacional de Pediatria | Available | Coyoacán | Mexico City | 4530 | Mexico |
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| H.C.U. de Valladolid | Available | Valladolid | 47003 | Mexico |
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| Hospital Universitario Reina Sofia | Available | Córdoba | 14004 | Spain |
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| Royal Manchester Children's Hospital - PPDS | Available | Manchester | M13 9WL | United Kingdom |
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| ID | Term |
|---|---|
| D016532 | Mucopolysaccharidosis II |
| ID | Term |
|---|---|
| D038901 | X-Linked Intellectual Disability |
| D008607 | Intellectual Disability |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D040181 | Genetic Diseases, X-Linked |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D020271 | Heredodegenerative Disorders, Nervous System |
| D009083 | Mucopolysaccharidoses |
| D002239 | Carbohydrate Metabolism, Inborn Errors |
| D008661 | Metabolism, Inborn Errors |
| D016464 | Lysosomal Storage Diseases |
| D017520 | Mucinoses |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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