Hunter Outcome Survey (HOS)

Last updated: October 25, 2024
Sponsor: Shire
Overall Status: Completed

Phase

N/A

Condition

Bone Marrow Disorder

Treatment

N/A

Clinical Study ID

NCT03292887
HOS
  • All Genders

Study 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

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:

  3. Prospective Participants: Signed and dated written informed consent from theparticipant or, for participants aged less than (<) 18 years (<16 years inScotland), 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 impairedparticipants, where applicable.OR

  4. Historical Participants: Signed and dated informed consent from theparticipant's LAR (where allowed by relevant individual country or siteregulations/laws). .

Exclusion

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enrolled in an interventional clinical trial are not eligible.Participants may re-enroll once they have completed or withdrawn from the otherclinical study.

  2. Participants receiving treatment for Hunter syndrome with an ERT product other thanElaprase are not eligible. Participants may enroll or re-enroll once they havestopped treatment with another ERT.

Study Design

Total Participants: 1443
Study Start date:
October 03, 2005
Estimated Completion Date:
February 16, 2023

Connect with a study center

  • Shire

    Lexington, Massachusetts 02421
    United States

    Site Not Available

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