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NCT00920647 · ClinicalTrials.gov registry record · Phase 1
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®
A Phase 1 study of Hunter Syndrome, sponsored by Shire.
- Completed
- Registry status
- Phase 1
- Development phase
- 16
- Enrollment target
- 3
- Study locations
NCT00920647 is a Phase 1 study of Hunter Syndrome that has completed, run by Shire. The registered enrollment target is 16 participants, below the 353-participant average among 5 other Hunter Syndrome trials with a reported enrollment target (95% lower). The trial reports 3 study locations across 2 states.
The verdict
NCT00920647, a Phase 1 study of Hunter Syndrome, has completed, sponsored by Shire.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 16 participants
- Enrollment target
- 3
- Study locations
Study Summary
Elaprase (idursulfase), a large molecular protein, is not expected to cross the blood brain barrier at therapeutic levels when administered intravenously. A new formulation of idursulfase, idursulfase-IT, that differs from that of the intravenous (IV) formulation, Elaprase, has been developed to be suitable for delivery into the cerebrospinal fluid (CSF) via intrathecal administration. This Phase I/II study is designed to obtain necessary safety and exposure data, as well as secondary and exploratory outcome measures, to be interpreted and used in the design of subsequent clinical trials.
Conditions Studied
Interventions
- OTHER Control
- DRUG Idursulfase IT (1 mg)
- DRUG Idursulfase IT (10 mg)
- DRUG Idursulfase IT (30 mg)
Study Locations (3)
Other
- Birmingham Children's Hospital - Birmingham
- Birmingham Children's Hospital NHS Foundation Trust - Birmingham
North Carolina
- University of North Carolina at Chapel Hill - Chapel Hill
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2009-11-18 |
| Est. Completion | 2012-10-29 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00920647
The ClinicalTrials.gov registry entry for NCT00920647 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 16 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 (95% 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 4 interventions - of which Control is the first listed.
NCT00920647 reports 3 study locations spanning 2 distinct geographic areas - top geographies include Other, North Carolina.
Frequently Asked Questions
What is clinical trial NCT00920647 about?
NCT00920647 is a clinical study titled "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®". Elaprase (idursulfase), a large molecular protein, is not expected to cross the blood brain barrier at therapeutic levels when administered intravenously. A new formulation of idursulfase, idursulfase-IT, that differs from that of the intravenous (IV) formulation, Elaprase, has been developed to be ...
What is the current status of trial NCT00920647?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2009-11-18. Estimated completion is 2012-10-29.
What conditions does trial NCT00920647 study?
This clinical trial studies the following conditions: Hunter Syndrome.
What interventions are being tested in trial NCT00920647?
The interventions under investigation include: Control (OTHER), Idursulfase IT (1 mg) (DRUG), Idursulfase IT (10 mg) (DRUG), Idursulfase IT (30 mg) (DRUG).
Who is sponsoring clinical trial NCT00920647?
This trial is sponsored by Shire, which has 245 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00920647 being conducted?
This trial has 3 study locations across North Carolina. 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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