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NCT02055118 · ClinicalTrials.gov registry record · Phase 2
Study of Intrathecal Idursulfase-IT Administered in Conjunction With Elaprase® in Pediatric Patients With Hunter Syndrome and Early Cognitive Impairment
A Phase 2 study of Hunter Syndrome, sponsored by Shire.
- Completed
- Registry status
- Phase 2
- Development phase
- 58
- Enrollment target
- 9
- Study locations
NCT02055118 is a Phase 2 study of Hunter Syndrome that has completed, run by Shire. The registered enrollment target is 58 participants, below the 345-participant average among 5 other Hunter Syndrome trials with a reported enrollment target (83% lower). The trial reports 9 study locations across 6 states.
The verdict
NCT02055118, a Phase 2 study of Hunter Syndrome, has completed, sponsored by Shire.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 58 participants
- Enrollment target
- 9
- Study locations
Study Summary
Study HGT-HIT-094 is a multicenter study designed to determine the effect on clinical parameters of neurodevelopmental status of monthly IT administration of idursulfase-IT 10 mg for 12 months in pediatric patients with Hunter syndrome and cognitive impairment who have previously received and tolerated a minimum of 4 months of therapy with Elaprase.
Conditions Studied
Interventions
- BIOLOGICAL idursulfase-IT
- OTHER No IT treatment
Study Locations (9)
Other
- Women's and Children's Hospital, 72 King William Road - North Adelaide
- Hôpital Femme Mère Enfant - Bron
- Hospital Infantil Universitario Niño Jesus - Madrid
- Royal Manchester Children's Hospital - Manchester
California
- Children's Hospital and Research Center at Oakland - Oakland
Illinois
- Ann & Robert H Lurie Children's Hospital of Chicago - Chicago
North Carolina
- University of North Carolina - Chapel Hill
Ontario
- The Hospital for Sick Children - Toronto
Mexico City
- Instituto Nacional de Pediatría - Coyoacán
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 58 participants |
| Start Date | 2014-03-24 |
| Est. Completion | 2017-09-28 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02055118
The ClinicalTrials.gov registry entry for NCT02055118 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 58 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 345-participant average among 5 other Hunter Syndrome trials with a reported enrollment target (83% lower). The listed sponsor is Shire, which has 245 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.
NCT02055118 reports 9 study locations spanning 6 distinct geographic areas - top geographies include Other, California, Illinois.
Frequently Asked Questions
What is clinical trial NCT02055118 about?
NCT02055118 is a clinical study titled "Study of Intrathecal Idursulfase-IT Administered in Conjunction With Elaprase® in Pediatric Patients With Hunter Syndrome and Early Cognitive Impairment". Study HGT-HIT-094 is a multicenter study designed to determine the effect on clinical parameters of neurodevelopmental status of monthly IT administration of idursulfase-IT 10 mg for 12 months in pediatric patients with Hunter syndrome and cognitive impairment who have previously received and tolera...
What is the current status of trial NCT02055118?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 58 participants. The study started on 2014-03-24. Estimated completion is 2017-09-28.
What conditions does trial NCT02055118 study?
This clinical trial studies the following conditions: Hunter Syndrome.
What interventions are being tested in trial NCT02055118?
The interventions under investigation include: idursulfase-IT (BIOLOGICAL), No IT treatment (OTHER).
Who is sponsoring clinical trial NCT02055118?
This trial is sponsored by Shire, which has 245 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02055118 being conducted?
This trial has 9 study locations across California, Illinois, North Carolina, Ontario, Mexico City. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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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
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A Safety and Dose Ranging Study of Idursulfase (Intrathecal) Administration Via an Intrathecal Drug Delivery Device in Pediatric Patients With Hunter Syndrome Who Have Central Nervous System Involvement and Are Receiving Treatment With Elaprase®
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Hunter Outcome Survey (HOS)
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.