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 studiesfor whom the benefit:risk ratio of continued treatment with idursulfase-IT remainspositive.
Not Provided
Drug: Idursulfase-IT
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.
Other Name: HGT-2310,TAK-609
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.
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
Coyoacan, Ciudad De Mexico, Mexico
H.C.U. de Valladolid
Valladolid, Mexico
Hospital Universitario Reina Sofia
Cordoba, Spain
Royal Manchester Children's Hospital - PPDS
Manchester, United Kingdom
Takeda Contact
+1877-825-3327
medinfoUS@takeda.com
Study Director, Study Director
Takeda