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 5308655, Arizona 5551752, United States
The Regents of the University of California
Oakland 5378538, California 5332921, United States
The Nemours Foundation
Wilmington 4145381, Delaware 4142224, United States
Jackson Memorial Hospital University of Miami
Miami 4164138, Florida 4155751, United States
Ann and Robert H Lurie Childrens Hospital of Chicago
Chicago 4887398, Illinois 4896861, United States
Washington University
Washington 4413621, Missouri 4398678, United States
Board of Regents of the University of Nebraska
Omaha 5074472, Nebraska 5073708, United States
Joseph M. Sanzari Children's Hospital
Hackensack 5098706, New Jersey 5101760, United States
NYU Langone Medical Center
New York 5128581, New York 5128638, United States
The University of North Carolina
Chapel Hill 4460162, North Carolina 4482348, United States
The Cleveland Clinic Foundation
Cleveland 5150529, Ohio 5165418, United States
Randall Children's Hospital at Legacy Emanuel
Portland 5746545, Oregon 5744337, United States
The Children's Hospital of Philadelphia
Philadelphia 4560349, Pennsylvania 6254927, United States
UPMC Childrens Hospital of Pittsburgh
Pittsburgh 5206379, Pennsylvania 6254927, United States
Vanderbilt Children's Hospital
Nashville 4644585, Tennessee 4662168, United States
Division of Medical Genetics, University of Utah
Salt Lake City 5780993, Utah 5549030, United States
Seattle Children's Hospital - PIN
Seattle 5809844, Washington 5815135, United States
Queensland Childrens Hospital
South Brisbane 2207259, Queensland 2152274, Australia
Instituto Nacional de Pediatria
Coyoacán 3530139, Mexico City 3527646, Mexico
H.C.U. de Valladolid
Valladolid 3514876, Mexico
Hospital Universitario Reina Sofia
Córdoba 2519240, Spain
Royal Manchester Children's Hospital - PPDS
Manchester 2643123, United Kingdom
Takeda Contact
+1877-825-3327
medinfoUS@takeda.com
Study Director, Study Director
Takeda