A Study of ELAPRASE in Treatment-naïve Participants With Hunter Syndrome (Mucopolysaccharidosis [MPS] II)
Public ClinicalTrials.gov record NCT05494593. 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.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
An Open-label, Multicenter, Phase 4 Study to Assess the Effects of a Prophylactic Immune Tolerizing Regimen in MPS II Treatment-Naïve Patients Planned to Receive ELAPRASE Who Are at Risk of Developing Persistent Neutralizing Antibodies
Study identification
- NCT ID
- NCT05494593
- Recruitment status
- Withdrawn
- Study type
- Interventional
- Phase
- Phase 4
- Lead sponsor
- Takeda
- Industry
- Enrollment
- Not listed
Conditions and interventions
Conditions
Interventions
- ELAPRASE Drug
- Intravenous Immunoglobulin (IVIG) Drug
- Methotrexate Drug
- Rituximab Drug
Drug
Eligibility (public fields only)
- Age range
- Up to 6 Years
- 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
- Feb 27, 2023
- Primary completion
- Aug 28, 2025
- Completion
- Aug 28, 2025
- Last update posted
- Dec 8, 2025
2023 – 2025
United States locations
- U.S. sites
- 8
- U.S. states
- 6
- U.S. cities
- 8
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Phoenix Childrens Hospital | Phoenix | Arizona | 85016 | — |
| Children's Hospital and Research Center at Oakland | Oakland | California | 94609 | — |
| Rady Childrens Hospital San Diego - PIN | San Diego | California | 92123 | — |
| The Lundquist Institute for BioMedical Innovation at Harbor-UCLA Medical Center | Torrance | California | 90502 | — |
| Ann and Robert H Lurie Childrens Hospital of Chicago | Chicago | Illinois | 60611 | — |
| Children's Hospitals and Clinics of Minnesota | Minneapolis | Minnesota | 55404 | — |
| NewYork-Presbyterian Morgan Stanley Children's Hospital | New York | New York | 10032 | — |
| The Cleveland Clinic Foundation | Twinsburg | Ohio | 44087 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05494593, 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 Dec 8, 2025 · Synced May 7, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05494593 live on ClinicalTrials.gov.