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

April 6, 2026 updated by: Takeda

Post-trial Access Program: Idursulfase-IT (HGT-2310) in Conjunction With Intravenous Elaprase® in Pediatric and Adult Patients With Hunter Syndrome and Cognitive Impairment

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.

Study Overview

Status

Available

Conditions

Intervention / Treatment

Study Type

Expanded Access

Expanded Access Type

  • Intermediate-size Population

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Queensland
      • South Brisbane, Queensland, Australia, QLD 4101
        • Available
        • Queensland Childrens Hospital
  • Mexico
      • Valladolid, Mexico, 47003
        • Available
        • H.C.U. de Valladolid
    • Mexico City
      • Coyoacán, Mexico City, Mexico, 4530
        • Available
        • Instituto Nacional de Pediatría
  • Spain
      • Córdoba, Spain, 14004
        • Available
        • Hospital Universitario Reina Sofía
  • United Kingdom
      • Manchester, United Kingdom, M13 9WL
        • Available
        • Royal Manchester Children's Hospital - PPDS
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85015
        • Available
        • Phoenix Childrens Hospital
    • California
      • Oakland, California, United States, 94609
        • Available
        • The Regents of the University of California
    • Delaware
      • Wilmington, Delaware, United States, 19803
        • Available
        • The Nemours Foundation
    • Florida
      • Miami, Florida, United States, 33101
        • Available
        • Jackson Memorial Hospital University of Miami
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Available
        • Ann and Robert H Lurie Childrens Hospital of Chicago
    • Missouri
      • Washington, Missouri, United States, 63130
        • Available
        • Washington University
    • Nebraska
      • Omaha, Nebraska, United States, 68198-5450
        • Available
        • Board of Regents of the University of Nebraska
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Available
        • Joseph M. Sanzari Children's Hospital
    • New York
      • New York, New York, United States, 10017
        • Available
        • NYU Langone Medical Center
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514
        • Available
        • The University of North Carolina
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Available
        • The Cleveland Clinic Foundation
    • Oregon
      • Portland, Oregon, United States, 97227
        • Available
        • Randall Children's Hospital at Legacy Emanuel
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Available
        • The Children's Hospital of Philadelphia
      • Pittsburgh, Pennsylvania, United States, 15224
        • Available
        • UPMC Childrens Hospital of Pittsburgh
    • Tennessee
      • Nashville, Tennessee, United States, 37232-7610
        • Available
        • Vanderbilt Children's Hospital
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • Available
        • Division of Medical Genetics, University of Utah
    • Washington
      • Seattle, Washington, United States, 98105
        • Available
        • Seattle Children's Hospital - PIN

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 18 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Takeda

Investigators

  • Study Director: Study Director, Takeda

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

March 20, 2023

First Submitted That Met QC Criteria

March 20, 2023

First Posted (Actual)

April 3, 2023

Study Record Updates

Last Update Posted (Actual)

April 13, 2026

Last Update Submitted That Met QC Criteria

April 6, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TAK-609-5005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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