JRCT ID: jRCT2031210508
Registered date:23/12/2021
Unituxin Intravenous Infusion 17.5mg / 5mL specific drug use-results survey (Survey of all cases)
Basic Information
Recruitment status | Recruiting |
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Health condition(s) or Problem(s) studied | neuroblastoma after high-dose chemotherapy |
Date of first enrollment | 23/12/2021 |
Target sample size | 120 |
Countries of recruitment | |
Study type | Observational |
Intervention(s) |
Outcome(s)
Primary Outcome | Safety prefecture side effect incidence rate Prognosis survey Overall survival rate at 5 years, Information about growth and developmental disorders, Presence or absence of safety considerations |
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Secondary Outcome | best overall response |
Key inclusion & exclusion criteria
Age minimum | Not applicable |
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Age maximum | Not applicable |
Gender | Both |
Include criteria | All patients receiving Unituxin after September 22, 2021 Patients with neuroblastoma after high-dose chemotherapy |
Exclude criteria | Patients with a history of hypersensitivity to the ingredients of Unituxin |
Related Information
Primary Sponsor | Medicine Development Center PMS unit |
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Secondary Sponsor | |
Source(s) of Monetary Support | |
Secondary ID(s) | Nil known |
Contact
Public contact | |
Name | PMS unit Medicine Development Center |
Address | 8-1, Akashi-cho, Chuo-ku, Tokyo 104-6591 Japan Tokyo Japan 104-6591 |
Telephone | +81-3-6740-7701 |
pms-md@ohara-ch.co.jp | |
Affiliation | OHARA Pharmaceutical Co., Ltd. |
Scientific contact | |
Name | PMS unit Medicine Development Center |
Address | 8-1, Akashi-cho, Chuo-ku, Tokyo 104-6591 Japan Tokyo Japan 104-6591 |
Telephone | +81-3-6740-7701 |
pms-md@ohara-ch.co.jp | |
Affiliation | OHARA Pharmaceutical Co., Ltd. |