An Observational Study Evaluating Anti-Idursulfase Serum Antibody Response in Hunter Syndrome Patients

Completed

Conditions studied: Hunter Syndrome

In brief

The objective of this study is to evaluate the effect of anti-idursulfase antibodies on idursulfase safety (measured by infusion related adverse events) between patients who develop anti-idursulfase antibodies and patients who do not after long-term idursulfase enzyme replacement therapy (ERT).

Key facts

Study ID

NCT00882921

Run by

Shire

People needed

26

Starts

2008-10-14

Expected to finish

2013-02-08

Last updated by the study team

2021-06-08

Who can join

Age: 5 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Patients must meet all of the following criteria to be considered eligible for enrollment:
• The patient is male and enrolled in the HOS (i.e., meets the entry criteria of a documented diagnosis of Hunter syndrome)
• The patient is ≥ 5 years-old
• The patient is on idursulfase treatment or scheduled to begin idursulfase treatment within 30 days of study enrollment
• The patient, patient's parent(s), or patient's legally authorized guardian must have voluntarily signed an Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved informed consent form after all relevant aspects of the study have been explained and discussed with the patient, patient's parent(s), or patient's legally authorized guardian.

You may not qualify if…

• Patients who meet any of the following criteria are not eligible for this study:
• The patient has received biologic/ERT products other than idursulfase, or other investigational product(s) for any reason within 30 days prior to study entry.
• The patient has a life expectancy of < 2 years
• The patient is unable to comply with the protocol, e.g., has a clinically relevant medical condition making implementation of the protocol difficult; has an uncooperative attitude; is unable to return for safety evaluations; or is otherwise unlikely to complete the study, as determined by the Investigator.

Where it is running

• Children's Hospital & Research Center Oakland — Oakland, California, United States
• Children's Hospitals and Clinics of Minnesota, Division of Genetics — Minneapolis, Minnesota, United States
• Hospital de Clinicas de Porto Alegre, Servico de Genetica Medica — Porto Alegre, Rio Grande do Sul, Brazil
• Birmingham Children's Hospital — Birmingham, United Kingdom
• Great Ormond Street Hospital — London, United Kingdom
• Central Manchester University Hospitals, St. Mary's Hospital — Manchester, United Kingdom

Full record on ClinicalTrials.gov

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