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NCT01506141 · ClinicalTrials.gov registry record · Phase 1
An Extension Study of HGT-HIT-045 Evaluating Long-Term Safety and Clinical Outcomes of Idursulfase-IT in Conjunction With Elaprase in Pediatric Participants With Hunter Syndrome and Cognitive Impairment
A Phase 1 study of Hunter Syndrome, sponsored by Takeda.
- Completed
- Registry status
- Phase 1
- Development phase
- 15
- Enrollment target
- 9
- Study locations
NCT01506141 is a Phase 1 study of Hunter Syndrome that has completed, run by Takeda. The registered enrollment target is 15 participants, below the 353-participant average among 5 other Hunter Syndrome trials with a reported enrollment target (96% lower). The trial reports 9 study locations across 9 states.
The verdict
NCT01506141, a Phase 1 study of Hunter Syndrome, has completed, sponsored by Takeda.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 15 participants
- Enrollment target
- 9
- Study locations
Study Summary
This extension study of HGT-HIT-045 is designed to collect long-term safety data in pediatric participants with Hunter syndrome and cognitive impairment who are receiving intrathecal (IT) idursulfase-IT and intravenous (IV) Elaprase enzyme replacement therapy.
Conditions Studied
Interventions
- DRUG Idursulfase-IT
- DRUG Elaprase
Study Locations (9)
Illinois
- Ann & Robert H Lurie Childrens Hospital of Chicago - Chicago
North Carolina
- University of North Carolina at Chapel Hill - Chapel Hill
Oregon
- Legacy Emanuel Hospital - Portland
Pennsylvania
- Children's Hospital of Pittsburgh of UPMC - Pittsburgh
Tennessee
- Vanderbilt Children's Hospital - Nashville
Utah
- University of Utah Hospital - Salt Lake City
Washington
- Seattle Children's Hospital - Seattle
British Columbia
- British Columbia Children's Hospital - Vancouver
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2010-08-01 |
| Est. Completion | 2024-04-30 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01506141
The ClinicalTrials.gov registry entry for NCT01506141 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 353-participant average among 5 other Hunter Syndrome trials with a reported enrollment target (96% lower). The listed sponsor is Takeda, which has 408 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Hunter Syndrome appearing as the primary indexed condition, and to 2 interventions - of which Idursulfase-IT is the first listed.
NCT01506141 reports 9 study locations spanning 9 distinct geographic areas - top geographies include Illinois, North Carolina, Oregon.
Frequently Asked Questions
What is clinical trial NCT01506141 about?
NCT01506141 is a clinical study titled "An Extension Study of HGT-HIT-045 Evaluating Long-Term Safety and Clinical Outcomes of Idursulfase-IT in Conjunction With Elaprase in Pediatric Participants With Hunter Syndrome and Cognitive Impairment". This extension study of HGT-HIT-045 is designed to collect long-term safety data in pediatric participants with Hunter syndrome and cognitive impairment who are receiving intrathecal (IT) idursulfase-IT and intravenous (IV) Elaprase enzyme replacement therapy.
What is the current status of trial NCT01506141?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2010-08-01. Estimated completion is 2024-04-30.
What conditions does trial NCT01506141 study?
This clinical trial studies the following conditions: Hunter Syndrome.
What interventions are being tested in trial NCT01506141?
The interventions under investigation include: Idursulfase-IT (DRUG), Elaprase (DRUG).
Who is sponsoring clinical trial NCT01506141?
This trial is sponsored by Takeda, which has 408 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01506141 being conducted?
This trial has 9 study locations across Illinois, North Carolina, Oregon, Pennsylvania, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Read our methodology - how this data is sourced, computed, and verified.
Related
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