Post-trial Access Program of Idursulfase-IT Along With Elaprase in Children With Hunter Syndrome

NCT05795361 | Unknown

• 1 other identifier: TAK-609-5005
• Study Type: expanded_access
• Target: N/A
• Locations: 5 countries
• Sites: 22

Brief Summary

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.

Conditions

Hunter Syndrome

Interventions

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.

Also known as: HGT-2310, TAK-609

Eligibility Criteria

• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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).

You may not qualify if:

• Participant has a condition that in the opinion of the treating physician may compromise their safety.
• Participant has a known hypersensitivity to idursulfase-IT or its components.

Sponsors & Collaborators

• Takeda: lead

Study Sites (22)

Phoenix Childrens Hospital

Phoenix, Arizona, 85015, United States

AVAILABLE

The Regents of the University of California

Oakland, California, 94609, United States

AVAILABLE

The Nemours Foundation

Wilmington, Delaware, 19803, United States

AVAILABLE

Jackson Memorial Hospital University of Miami

Miami, Florida, 33101, United States

AVAILABLE

Ann and Robert H Lurie Childrens Hospital of Chicago

Chicago, Illinois, 60611, United States

AVAILABLE

Washington University

Washington, Missouri, 63130, United States

AVAILABLE

Board of Regents of the University of Nebraska

Omaha, Nebraska, 68198-5450, United States

AVAILABLE

Joseph M. Sanzari Children's Hospital

Hackensack, New Jersey, 07601, United States

AVAILABLE

NYU Langone Medical Center

New York, New York, 10017, United States

AVAILABLE

The University of North Carolina

Chapel Hill, North Carolina, 27514, United States

AVAILABLE

The Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

AVAILABLE

Randall Children's Hospital at Legacy Emanuel

Portland, Oregon, 97227, United States

AVAILABLE

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

AVAILABLE

UPMC Childrens Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15224, United States

AVAILABLE

Vanderbilt Children's Hospital

Nashville, Tennessee, 37232-7610, United States

AVAILABLE

Division of Medical Genetics, University of Utah

Salt Lake City, Utah, 84112, United States

AVAILABLE

Seattle Children's Hospital - PIN

Seattle, Washington, 98105, United States

AVAILABLE

Queensland Childrens Hospital

South Brisbane, Queensland, QLD 4101, Australia

AVAILABLE

Instituto Nacional de Pediatria

Coyoacán, Mexico City, 4530, Mexico

AVAILABLE

H.C.U. de Valladolid

Valladolid, 47003, Mexico

AVAILABLE

Hospital Universitario Reina Sofia

Córdoba, 14004, Spain

AVAILABLE

Royal Manchester Children's Hospital - PPDS

Manchester, M13 9WL, United Kingdom

AVAILABLE

Related Links

• To obtain more information on the study, click here/on this link
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MeSH Terms

Conditions

Mucopolysaccharidosis II

Condition Hierarchy (Ancestors)

X-Linked Intellectual Disability; Intellectual Disability; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Genetic Diseases, X-Linked; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Heredodegenerative Disorders, Nervous System; Mucopolysaccharidoses; Carbohydrate Metabolism, Inborn Errors; Metabolism, Inborn Errors; Lysosomal Storage Diseases; Mucinoses; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Central Study Contacts

Takeda Contact

CONTACT

+1877-825-3327; medinfoUS@takeda.com

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2023
• First Posted: April 3, 2023
• Last Updated: April 13, 2026

Record last verified: 2026-04

Locations

AU (1); ES (1); ME (2); GB (1); US (17)