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®

Completed

Conditions studied: Hunter Syndrome

In brief

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.

Key facts

Study ID

NCT00937794

Run by

Shire

People needed

33

Starts

2009-07-02

Expected to finish

2011-07-13

Last updated by the study team

2021-06-14

Who can join

Age: 3 and older, up to 18. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States
• Birmingham Children's Hospital — Birmingham, United Kingdom

Full record on ClinicalTrials.gov

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