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

Primary Purpose

Hunter Syndrome

Status
Available
Phase
Locations
Study Type
Expanded Access
Intervention
Idursulfase-IT
Sponsored by
Takeda
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for Hunter Syndrome

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria: 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). Exclusion Criteria: 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.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    March 20, 2023
    Last Updated
    April 6, 2023
    Sponsor
    Takeda
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05795361
    Brief Title
    Post-trial Access Program of Idursulfase-IT Along With Elaprase in Children With Hunter Syndrome
    Official Title
    Post-trial Access Program: Idursulfase-IT (HGT-2310) in Conjunction With Intravenous Elaprase in Pediatric Patients With Hunter Syndrome and Cognitive Impairment
    Study Type
    Expanded Access

    2. Study Status

    Record Verification Date
    April 2023
    Overall Recruitment Status
    Available
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Takeda

    4. Oversight

    5. Study Description

    Brief Summary
    This post-trial access program is to allow continued access for people who participated and are benefitting from treatment on the HGT-HIT-046 (NCT01506141) or SHP609-302 (NCT02412787) studies, which will be closed down. Idursulfase-IT also known as TAK-609, is a medicine to help treat Hunter Syndrome and issues with remembering, learning new things, and concentrating, also called cognitive impairment.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hunter Syndrome

    7. Study Design

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Idursulfase-IT
    Other Intervention Name(s)
    HGT-2310, TAK-609
    Intervention Description
    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.

    10. Eligibility

    Sex
    Male
    Gender Based
    Yes
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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). Exclusion Criteria: 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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Takeda Contact
    Phone
    +1877-825-3327
    Email
    medinfoUS@takeda.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Study Director
    Organizational Affiliation
    Takeda
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Links:
    URL
    https://clinicaltrials.takeda.com/study-detail/1a50b2ee12ee4e80?idFilter=%5B%22TAK-609-5005%22%5D
    Description
    To obtain more information on the study, click here/on this link

    Learn more about this trial

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

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