Status:
COMPLETED
An Observational Study Evaluating Anti-Idursulfase Serum Antibody Response in Hunter Syndrome Patients
Lead Sponsor:
Shire
Conditions:
Hunter Syndrome
Eligibility:
MALE
5+ years
Brief Summary
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 a...
Detailed Description
This study is being conducted to satisfy post-marketing commitments to monitor anti-idursulfase antibody development in Hunter syndrome patients after long-term idursulfase enzyme replacement therapy....
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
October 14 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 8 2013
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT00882921
Start Date
October 14 2008
End Date
February 8 2013
Last Update
June 8 2021
Active Locations (6)
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1
Children's Hospital & Research Center Oakland
Oakland, California, United States, 94609
2
Children's Hospitals and Clinics of Minnesota, Division of Genetics
Minneapolis, Minnesota, United States, 55404
3
Hospital de Clinicas de Porto Alegre, Servico de Genetica Medica
Porto Alegre, Rio Grande do Sul, Brazil, 90035-903
4
Birmingham Children's Hospital
Birmingham, United Kingdom, B46NH