Back to resultsPost-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
About this trial
This is an expanded access trial for Hunter Syndrome
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.
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
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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