UMIN ID: UMIN000054325
Registered date:07/05/2024
Drug Use-Results Survey of PIASKY for Injection 340mg (All-Patient Surveillance) -Paroxysmal nocturnal hemoglobinuria-
Basic Information
| Recruitment status | Pending |
|---|---|
| Health condition(s) or Problem(s) studied | Paroxysmal nocturnal hemoglobinuria |
| Date of first enrollment | 2024/05/31 |
| Target sample size | 100 |
| Countries of recruitment | Japan |
| Study type | Observational |
| Intervention(s) |
Outcome(s)
| Primary Outcome | Occurrence of adverse drug reactions Changes in LDH and CH50 from baseline |
|---|---|
| Secondary Outcome |
Key inclusion & exclusion criteria
| Age minimum | Not applicable |
|---|---|
| Age maximum | Not applicable |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | None |
Related Information
| Primary Sponsor | Chugai Pharmaceutical Co. Ltd. |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Chugai Pharmaceutical Co. Ltd. |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Ayako Murayama |
| Address | 1-1 Nihonbashi-muromachi 2-chome, Chuo-ku Tokyo, Japan Japan 1038324 |
| Telephone | 03-3281-6611 |
| murayamaayk@chugai-pharm.co.jp | |
| Affiliation | Chugai Pharmaceutical Co. Ltd Safety Science 2 Department |
| scientific contact | |
| Name | Shinya Takemoto |
| Address | 1-1 Nihonbashi-muromachi 2-chome, Chuo-ku Tokyo, Japan Japan |
| Telephone | 03-3281-6611 |
| takemotosny@chugai-pharm.co.jp | |
| Affiliation | Chugai Pharmaceutical Co. Ltd Safety Science 2 Department |