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

ClinicalTrials.gov ID: NCT05795361

Public ClinicalTrials.gov record NCT05795361. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Sep 7, 2026, 1:15 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 identification

NCT ID: NCT05795361
Recruitment status: Available
Study type: Expanded access
Phase: Not listed
Lead sponsor: Takeda; Industry
Enrollment: Not listed

Conditions and interventions

Conditions

Hunter Syndrome

Interventions

Idursulfase-IT Drug

Drug

Eligibility (public fields only)

Age range: Not listed
Sex: Male
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Not listed
Primary completion: Not listed
Completion: Not listed
Last update posted: Apr 12, 2026

United States locations

U.S. sites: 17
U.S. states: 16
U.S. cities: 17

Facility	City	State	ZIP	Site status
Phoenix Childrens Hospital	Phoenix	Arizona	85015	Available
The Regents of the University of California	Oakland	California	94609	Available
The Nemours Foundation	Wilmington	Delaware	19803	Available
Jackson Memorial Hospital University of Miami	Miami	Florida	33101	Available
Ann and Robert H Lurie Childrens Hospital of Chicago	Chicago	Illinois	60611	Available
Washington University	Washington	Missouri	63130	Available
Board of Regents of the University of Nebraska	Omaha	Nebraska	68198-5450	Available
Joseph M. Sanzari Children's Hospital	Hackensack	New Jersey	07601	Available
NYU Langone Medical Center	New York	New York	10017	Available
The University of North Carolina	Chapel Hill	North Carolina	27514	Available
The Cleveland Clinic Foundation	Cleveland	Ohio	44195	Available
Randall Children's Hospital at Legacy Emanuel	Portland	Oregon	97227	Available
The Children's Hospital of Philadelphia	Philadelphia	Pennsylvania	19104	Available
UPMC Childrens Hospital of Pittsburgh	Pittsburgh	Pennsylvania	15224	Available
Vanderbilt Children's Hospital	Nashville	Tennessee	37232-7610	Available
Division of Medical Genetics, University of Utah	Salt Lake City	Utah	84112	Available
Seattle Children's Hospital - PIN	Seattle	Washington	98105	Available

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 5 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT05795361, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Apr 12, 2026 · Synced Sep 7, 2026

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The complete protocol, eligibility criteria, and contact information for NCT05795361 live on ClinicalTrials.gov.

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