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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: |
NCT02618512 |
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Date of registration:
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21/10/2015 |
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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 Open Label Study in Previously Studied, SBC-103 Treatment Naïve MPS IIIB Subjects to Investigate the Safety, Pharmacokinetics, and Pharmacodynamics/Efficacy of SBC-103 Administered Intravenously
CL01-T |
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Scientific title:
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A Phase I/II Open Label Study in Previously Studied, SBC-103 Treatment Naïve MPS IIIB Subjects to Investigate the Safety, Pharmacokinetics, and Pharmacodynamics/Efficacy of SBC-103 Administered Intravenously |
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Date of first enrolment:
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October 15, 2015 |
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Target sample size:
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3 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT02618512 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 1/Phase 2
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Countries of recruitment
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United Kingdom
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Key inclusion & exclusion criteria
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Participants from NGU-CL01 study were enrolled into the NGLU-CL01-T study. Subjects who met
all of the inclusion criteria and none of the exclusion criteria were eligible to
participate in this study.
Age minimum:
5 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Sanfilippo B
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Mucopolysaccharidosis III, Type B (MPS IIIB)
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Intervention(s)
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Drug: SBC-103
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Primary Outcome(s)
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Safety and Tolerability of SBC-103
[Time Frame: Planned duration was baseline to 164 weeks but due to early termination of the study, actual is 96 weeks.]
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Secondary ID(s)
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NGLU-CL01-T
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2015-001983-20
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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