Unique ID issued by UMIN | UMIN000049385 |
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Receipt number | R000056234 |
Scientific Title | Cablivi Injection 10mg Drug Use Investigation for patients with aTTP |
Date of disclosure of the study information | 2022/11/01 |
Last modified on | 2023/03/28 11:39:30 |
Cablivi Injection 10mg Drug Use Investigation for patients with aTTP
Cablivi Injection 10mg Drug Use Investigation for patients with aTTP
Cablivi Injection 10mg Drug Use Investigation for patients with aTTP
Cablivi Injection 10mg Drug Use Investigation for patients with aTTP
Japan |
Acquired thrombotic thrombocytopenic purpura
Hematology and clinical oncology |
Others
NO
All patients with acquired thrombotic thrombocytopenic purpura will be surveyed to collect information on safety and efficacy of drug in clinical practice and to assess the following
(1)The occurrence of bleeding events, serious hypersensitivity reactions, bleeding in combination with antithrombotic agents, safety in patients with hepatic impairment, safety with repeated administration, use in pediatric patients 12 years old or older and body weight 40 kg or over.
(2)Factors that may affect safety
(3)Efficacy of Cablivi in real world medical practice
Safety,Efficacy
Incidence during the observation period of adverse drug reaction mainly related to the safety specifications
Observational
Not applicable |
Not applicable |
Male and Female
All patients treated with Cablivi
NA
120
1st name | Masahiro |
Middle name | |
Last name | Tamura |
Medical Affairs
Post-authorization regulatory studies
163-1488
3-20-2, Nishi Shinjyuku, Shinjuku-ku, Tokyo
03-6301-3867
Sanofi_Medical@sanofi.com
1st name | Masahiro |
Middle name | |
Last name | Tamura |
Medical Affairs
Post-authorization regulatory studies
163-1488
3-20-2, Nishi Shinjyuku, Shinjuku-ku, Tokyo
03-6301-3867
Sanofi_Medical@sanofi.com
Sanofi K.K.
NA
Profit organization
Japan Conference of Clinical Research
1-13-23, Minamiikebukuro, Toshima-ku, Tokyo
03-6868-7022
jccr-info@jccr.jp
NO
2022 | Year | 11 | Month | 01 | Day |
Unpublished
Enrolling by invitation
2022 | Year | 09 | Month | 26 | Day |
2022 | Year | 10 | Month | 21 | Day |
2022 | Year | 12 | Month | 23 | Day |
2031 | Year | 03 | Month | 31 | Day |
This is an all-case surveillance
2022 | Year | 11 | Month | 01 | Day |
2023 | Year | 03 | Month | 28 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056234
Research Plan | |
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Registered date | File name |
Research case data | |
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Registered date | File name |