Status:
COMPLETED
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®
Lead Sponsor:
Shire
Conditions:
Hunter Syndrome
Eligibility:
MALE
32-18 years
Brief 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 ...
Eligibility Criteria
Inclusion
- The patient is male and is ≥3 and \<18 years of age
- The patient is currently receiving weekly IV infusions of Elaprase.
- The patient, patient's parent(s), or legally authorized guardian(s) has voluntarily signed an Institutional Review Board / Independent Ethics Committee-approved informed consent form after all relevant aspects of the study have been explained and discussed with the patient. The guardians' consent and subject's assent, as relevant, must be obtained.
Exclusion
- The patient has a CNS shunt.
- The patient has received a hematopoietic stem cell transplant.
- The patient is currently enrolled in a clinical trial.
- The patient has a significant medical or psychiatric comorbidity(ies) that might affect study data or confound the integrity of study results.
Key Trial Info
Start Date :
July 2 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 13 2011
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT00937794
Start Date
July 2 2009
End Date
July 13 2011
Last Update
June 14 2021
Active Locations (2)
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1
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599
2
Birmingham Children's Hospital
Birmingham, United Kingdom, B46NH