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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: Completed Phase 2 study of Hunter Syndrome, sponsored by Shire.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The DAS-II was used to assess cognitive development in all randomized participants. The GCA standard score of the DAS-II was used to obtain a general measure of cognitive ability. The GCA score represent a score (mean = 100 and standard deviation of 15) on which higher scores indicate a higher level of cognitive ability. The score ranges from 30 to 170. A positive change value indicates improvement in cognitive ability.
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 |
What the finished NCT02055118 record still lists
NCT02055118 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 58 participants, a relatively small participant target, below the 345-participant average among 5 other Hunter Syndrome trials with a reported enrollment target (83% lower).
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 lists 9 locations in 6 states (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.
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