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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT00882921 |
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Date of registration:
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16/04/2009 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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An Observational Study Evaluating Anti-Idursulfase Serum Antibody Response in Hunter Syndrome Patients
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Scientific title:
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A Multi-Center Observational Study Evaluating Anti-Idursulfase Serum Antibody Response in Hunter Syndrome Patients Enrolled in the Hunter Outcome Survey (HOS) Receiving Idursulfase Enzyme Replacement Therapy |
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Date of first enrolment:
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October 14, 2008 |
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Target sample size:
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26 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00882921 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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Brazil
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United Kingdom
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United States
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Contacts
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Name:
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Study Director |
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Address:
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Telephone:
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Email:
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Affiliation:
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Shire |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
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 Criteria:
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.
Age minimum:
5 Years
Age maximum:
N/A
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Hunter Syndrome
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Intervention(s)
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Biological: Idursulfase
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Primary Outcome(s)
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Infusion-Related Adverse Event (IRAE) Rates Between IgG Anti-idursulfase Antibody Positive (Ab+) and Anti-idursulfase IgG Antibody Negative (Ab-) Patients
[Time Frame: Baseline to 109 Weeks]
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Secondary Outcome(s)
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Change From Baseline in uGAG Levels to 109 Weeks
[Time Frame: Baseline to 109 Weeks]
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Secondary ID(s)
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HGT-ELA-042
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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