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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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16 December 2017 |
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Main ID: |
NCT01602601 |
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Date of registration:
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17/05/2012 |
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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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A Study to Test the Possibility of Cross Reaction Induced by the Idursulfase Drug to GSK2788723
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Scientific title:
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A Study to Test the Possibility of Cross Reaction of the Antibodies Induced by the ELAPRASE (R) to GSK2788723 ELAPRASE is a Trade Mark Owned by a Third Party |
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Date of first enrolment:
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April 9, 2012 |
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Target sample size:
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10 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01602601 |
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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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N/A
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Countries of recruitment
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Japan
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Contacts
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Name:
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GSK Clinical Trials |
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Address:
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Telephone:
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Email:
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Affiliation:
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GlaxoSmithKline |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
A subject will be eligible for inclusion in this study only if patient meets criteria 1 and
2 or 1 and 3:
- Diagnosed with Hunter syndrome
- Patients with Hunter syndrome who are being treated with idursulfase
- Patients with Hunter syndrome who are naïve of idursulfase treatment (if possible*)
*This study will also attempt to recruit 1 patient who has never received idursulfase.
If a naïve patient has not been identified within an agreed amount of time between GSK
and the investigator, the study will concluded without this sample
Exclusion Criteria:
- Subjects who are currently participating in another clinical trial are not permitted
to be enrolled in this study.
Age minimum:
N/A
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Mucopolysaccharidosis II
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Intervention(s)
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Drug: Idursulfase
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Drug: GSK2788723
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Primary Outcome(s)
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Level and capability of binding and neutralizing antibodies induced by idursulfase after the administration of idursulfase
[Time Frame: 1 Day]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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