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
Brief Summary

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.

Detailed Description

Not Provided

Available
Intermediate-size Population
Hunter Syndrome

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

Eligibility Criteria

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.

Eligibility Gender
Male
Eligibility Age
Minimum: N/A ~ Maximum: N/A
Countries
Australia
Mexico
Spain
United Kingdom
United States
Locations

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

Contacts

Takeda Contact
+1877-825-3327
medinfoUS@takeda.com

Study Director, Study Director
Takeda

NCT Number
MeSH Terms
Mucopolysaccharidosis II
Syndrome