Hunter Outcome Survey (HOS)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1443 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-10-03

Study Completion Date

2023-02-16

Brief Summary

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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.

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Detailed Description

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Conditions

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Hunter Syndrome

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Elaprase Treated

Participants with Hunters Syndrome received or receiving treatment with Elaprase as prescribed by their physician following locally approved prescribing information.

No interventions assigned to this group

Elaprase Non-Treated

Participants received no treatment for Hunters Syndrome.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

1. Diagnosis of Hunter syndrome (biochemically and/or genetically)
2. Signed and dated written informed consent, as per either a or b below:

1. 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
2. Historical Participants: Signed and dated informed consent from the participant's LAR (where allowed by relevant individual country or site regulations/laws). .

Exclusion Criteria

1. 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 Participants may re-enroll once they have completed or withdrawn from the other clinical study.
2. 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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No