The Long-term Safety Study of Idursulfase-beta in Hunter Syndrome(Mucopolysaccharidosis II) Patients

  • STATUS
    Recruiting
  • participants needed
    34
  • sponsor
    Green Cross Corporation
Updated on 7 November 2020
mucopolysaccharidosis
idursulfase

Summary

The objective of this study is to evaluate the long term safety and efficacy of once weekly dosing of idurasulfase-beta 0.5mg/kg administered in Hunter Syndrome(Mucopolysaccharidosis II) Patients

Details
Condition Hunter's Syndrome
Clinical Study IdentifierNCT02044692
SponsorGreen Cross Corporation
Last Modified on7 November 2020

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients who have a diagnosis of Hunter syndrome(Mucopolysaccharidosis II)
Patients who are administered idurasulfase-beta or willing to be administered idurasulfase-beta
Patient's parent(s), or patient's legal guardian must have given voluntary written consent to participate in the study

Exclusion Criteria

Patients who have participated in any other blind clinical trials
Patient who cannot be tracked about safety
Patients who are judged disqualified to participate clinical trials by investigator for other causes
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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