A 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®
| Status: | Completed |
|---|---|
| Conditions: | Metabolic |
| Therapuetic Areas: | Pharmacology / Toxicology |
| Healthy: | No |
| Age Range: | Any - 18 |
| Updated: | 3/30/2013 |
| Start Date: | July 2009 |
| End Date: | February 2012 |
| Contact: | Ann Barbier, MD, PhD |
| Email: | abarbier@shire.com |
| Phone: | 781-482-9282 |
A Screening Study to Identify Pediatric Patients With Hunter Syndrome Who Demonstrate Evidence of Central Nervous System 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.
Inclusion Criteria:
1. The patient is male and is ≥3 and <18 years of age
2. The patient is currently receiving weekly IV infusions of Elaprase.
3. 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 Criteria:
1. The patient has a CNS shunt.
2. The patient has received a hematopoietic stem cell transplant.
3. The patient is currently enrolled in a clinical trial.
4. The patient has a significant medical or psychiatric comorbidity(ies) that might
affect study data or confound the integrity of study results.
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