Status:
COMPLETED
Hunter Outcome Survey (HOS)
Lead Sponsor:
Shire
Conditions:
Hunter Syndrome
Eligibility:
All Genders
Brief Summary
The purpose of this study is to collect data that will increase understanding of Hunter syndrome. The data from HOS may provide guidance to healthcare professionals about disease treatment options.
Eligibility Criteria
Inclusion
- Diagnosis of Hunter syndrome (biochemically and/or genetically)
- Signed and dated written informed consent, as per either a or b below:
- Prospective Participants: Signed and dated written informed consent from the participant or, for participants aged less than (\<) 18 years (\<16 years in Scotland), parent and/or participant's legally authorized representative (LAR), and assent of the minor where applicable.
- informed consent must be obtained from LARs for cognitively impaired participants, where applicable.
- OR
- Historical Participants: Signed and dated informed consent from the participant's LAR (where allowed by relevant individual country or site regulations/laws). .
Exclusion
- Participants enrolled in an interventional clinical trial are not eligible. Participants may re-enroll once they have completed or withdrawn from the other clinical study.
- Participants receiving treatment for Hunter syndrome with an ERT product other than Elaprase are not eligible. Participants may enroll or re-enroll once they have stopped treatment with another ERT.
Key Trial Info
Start Date :
October 3 2005
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 16 2023
Estimated Enrollment :
1443 Patients enrolled
Trial Details
Trial ID
NCT03292887
Start Date
October 3 2005
End Date
February 16 2023
Last Update
October 28 2024
Active Locations (1)
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1
Shire
Lexington, Massachusetts, United States, 02421