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NCT00937794 · ClinicalTrials.gov registry record
Screening Study to Identify Pediatric Patients With Hunter Syndrome Who Demonstrate Evidence of Central Nervous System (CNS) Involvement and Who Are Currently Receiving Treatment With Elaprase®
A clinical trial, sponsored by Shire.
- Completed
- Registry status
- 33
- Enrollment target
NCT00937794: Completed study, sponsored by Shire.
NCT00937794 is a clinical trial that has completed, run by Shire. The registered enrollment target is 33 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00937794 has completed, sponsored by Shire.
- COMPLETED
- Registry status
- 33 participants
- Enrollment target
Study Summary
This study is being conducted to identify pediatric patients with Hunter syndrome who have neurodevelopmental disease characteristics, who are currently receiving treatment with Elaprase, and who may be suitable to participate in a clinical study with an investigational agent.
Primary Outcome
Standardized tests were used to identify patients who were receiving treatment with Elaprase, had cognitive impairment, and were suitable to participate in the follow-on clinical study (HGT-HIT-045). Assessments included: 1-Cognition: The Differential Ability Scale, Second Edition (DAS-II) or the Bayley Scales of Infant Development, Third Edition (BSID-III); 2-Adaptive Behavior: The Scale of Independent Behavior-Revised (SIB-R); 3-Executive Function: The Behavior Rating Inventory of Executive Fu
Interventions
- BEHAVIORAL Neurobehavioral testing
- OTHER Visual and auditory assessments
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 33 participants |
| Start Date | 2009-07-02 |
| Est. Completion | 2011-07-13 |
What the finished NCT00937794 record still lists
NCT00937794 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 33 participants, a relatively small participant target.
The record links to 0 conditions, and to 2 interventions - of which Neurobehavioral testing is the first listed.
NCT00937794 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00937794 about?
NCT00937794 is a clinical study titled "Screening Study to Identify Pediatric Patients With Hunter Syndrome Who Demonstrate Evidence of Central Nervous System (CNS) Involvement and Who Are Currently Receiving Treatment With Elaprase®". This study is being conducted to identify pediatric patients with Hunter syndrome who have neurodevelopmental disease characteristics, who are currently receiving treatment with Elaprase, and who may be suitable to participate in a clinical study with an investigational agent.
What is the current status of trial NCT00937794?
This trial is currently completed. The enrollment target is 33 participants. The study started on 2009-07-02. Estimated completion is 2011-07-13.
What interventions are being tested in trial NCT00937794?
The interventions under investigation include: Neurobehavioral testing (BEHAVIORAL), Visual and auditory assessments (OTHER).
Who is sponsoring clinical trial NCT00937794?
This trial is sponsored by Shire, which has 245 total clinical trials registered on ClinicalTrials.gov.
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