UMIN ID: UMIN000042673
Registered date:25/12/2020
XOFLUZA Specified Drug Use-results Survey (high-risk subjects in prophylaxis use)
Basic Information
| Recruitment status | Pending |
|---|---|
| Health condition(s) or Problem(s) studied | Prophylaxis for influenza virus infection |
| Date of first enrollment | 2021/01/01 |
| Target sample size | 120 |
| Countries of recruitment | Japan |
| Study type | Observational |
| Intervention(s) |
Outcome(s)
| Primary Outcome | Incidence rates of adverse drug reactions for household members at specific high-risk of XOFLUZA in prophylaxis use |
|---|---|
| Secondary Outcome | Prevalence rates of influenza virus infections for household members at specific high-risk of XOFLUZA in prophylaxis use |
Key inclusion & exclusion criteria
| Age minimum | Not applicable |
|---|---|
| Age maximum | Not applicable |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | NA |
Related Information
| Primary Sponsor | Shionogi & Co., Ltd. |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Shionogi & Co., Ltd. |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Kanae Hara |
| Address | 1-8, Doshomachi 3-Chome, Chuo-ku, Osaka 541-0045, Japan 541-0045 |
| Telephone | +81-6-6209-6974 |
| kanae.hara@shionogi.co.jp | |
| Affiliation | Shionogi & Co., Ltd. Pharmacovigilance Department |
| scientific contact | |
| Name | Masaru Sawada |
| Address | 1-8, Doshomachi 3-Chome, Chuo-ku, Osaka 541-0045, Japan |
| Telephone | +81-6-6209-6974 |
| masaru.sawada@shionogi.co.jp | |
| Affiliation | Shionogi & Co., Ltd. Pharmacovigilance Department |