JRCT ID: jRCT2080224970
Registered date:29/11/2019
Basic Information
Recruitment status | completed |
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Health condition(s) or Problem(s) studied | |
Date of first enrollment | 27/03/2020 |
Target sample size | 60 |
Countries of recruitment | Japan,North America,South America,Europe,null |
Study type | Interventional |
Intervention(s) | investigational material(s) Generic name etc : INN of investigational material : eliglustat Therapeutic category code : 399 Agents affecting metabolism, n.e.c. Dosage and Administration for Investigational material : Generic name etc : INN of investigational material : imiglucerase Therapeutic category code : 399 Agents affecting metabolism, n.e.c. Dosage and Administration for Investigational material : control material(s) Generic name etc : INN of investigational material : - Therapeutic category code : Dosage and Administration for Investigational material : |
Outcome(s)
Primary Outcome | pharmacokinetics pharmacokinetics safety |
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Secondary Outcome | efficacy efficacy efficacy efficacy efficacy efficacy efficacy efficacy |
Key inclusion & exclusion criteria
Age minimum | >= 2age old |
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Age maximum | <= 17age old |
Gender | Both |
Include criteria | |
Exclude criteria |
Related Information
Primary Sponsor | |
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Secondary Sponsor | |
Source(s) of Monetary Support | |
Secondary ID(s) | NCT03485677,2016-000301-37,JapicCTI-195058 |
Contact
Public contact | |
Name | |
Address | |
Telephone | +81-3-6301-3670 |
clinical-trials-jp@sanofi.com | |
Affiliation | |
Scientific contact | |
Name | |
Address | |
Telephone | +81-3-6301-3670 |
clinical-trials-jp@sanofi.com | |
Affiliation |