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NCT06149403 · ClinicalTrials.gov registry record · Phase 3
A Study to Investigate the Efficacy and Safety of OTL-203 in Subjects With MPS-IH Compared With Standard of Care With Allogeneic HSCT
A Phase 3 study of MPS-IH (Hurler Syndrome), sponsored by Orchard Therapeutics.
- Active
- Registry status
- Phase 3
- Development phase
- 41
- Enrollment target
- 5
- Study locations
NCT06149403 is a Phase 3 study of MPS-IH (Hurler Syndrome) that is active but no longer recruiting, run by Orchard Therapeutics. The registered enrollment target is 41 participants. The trial reports 5 study locations across 2 states.
The verdict
NCT06149403, a Phase 3 study of MPS-IH (Hurler Syndrome), is active but no longer recruiting, sponsored by Orchard Therapeutics.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 41 participants
- Enrollment target
- 5
- Study locations
Study Summary
A multi-center randomized clinical trial to compare OTL-203 (gene therapy) with stem cell transplant (standard of care) in patients with MPS-IH (Hurler syndrome).
Conditions Studied
Interventions
- GENETIC Experimental: OTL-203
- GENETIC Active Comparator: Allo-HSCT
Study Locations (5)
Other
- Ospedale San Raffaele - Milan
- Princess Maxima Center - Utrecht
- UMC Utrecht - Utrecht
- Manchester University NHS Foundation Trust Blood and Marrow Transplant Programme, Royal Manchester Children's Hospital - Manchester
Minnesota
- University of Minnesota, Pediatrics - Minneapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 41 participants |
| Start Date | 2023-12-11 |
| Est. Completion | 2031-03 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06149403
The ClinicalTrials.gov registry entry for NCT06149403 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 41 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Orchard Therapeutics, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with MPS-IH (Hurler Syndrome) appearing as the primary indexed condition, and to 2 interventions - of which Experimental: OTL-203 is the first listed.
NCT06149403 reports 5 study locations spanning 2 distinct geographic areas - top geographies include Other, Minnesota.
Frequently Asked Questions
What is clinical trial NCT06149403 about?
NCT06149403 is a clinical study titled "A Study to Investigate the Efficacy and Safety of OTL-203 in Subjects With MPS-IH Compared With Standard of Care With Allogeneic HSCT". A multi-center randomized clinical trial to compare OTL-203 (gene therapy) with stem cell transplant (standard of care) in patients with MPS-IH (Hurler syndrome).
What is the current status of trial NCT06149403?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 41 participants. The study started on 2023-12-11. Estimated completion is 2031-03.
What conditions does trial NCT06149403 study?
This clinical trial studies the following conditions: MPS-IH (Hurler Syndrome).
What interventions are being tested in trial NCT06149403?
The interventions under investigation include: Experimental: OTL-203 (GENETIC), Active Comparator: Allo-HSCT (GENETIC).
Who is sponsoring clinical trial NCT06149403?
This trial is sponsored by Orchard Therapeutics, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06149403 being conducted?
This trial has 5 study locations across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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