Unique ID issued by UMIN | UMIN000032515 |
---|---|
Receipt number | R000037081 |
Scientific Title | HEMLIBRA Subcutaneous injection General Drug Use Surveillance(in Hemophilia A with Inhibitors). |
Date of disclosure of the study information | 2018/05/21 |
Last modified on | 2022/12/28 06:43:49 |
HEMLIBRA Subcutaneous injection General Drug Use Surveillance(in Hemophilia A with Inhibitors).
HEMLIBRA General Drug Use Surveillance(in Hemophilia A).
HEMLIBRA Subcutaneous injection General Drug Use Surveillance(in Hemophilia A with Inhibitors).
HEMLIBRA General Drug Use Surveillance(in Hemophilia A).
Japan |
Hemophilia A
Hematology and clinical oncology | Pediatrics | Blood transfusion |
Others
NO
By assessing the following aspects of hemlibra under actual use.
(1)Occurrence state of bleeding and its treatment state.
(2)Occurrence state of TE and/or TMA.
(3)Other ADRs.
Efficacy
1. The incidence of ADRs.
2. The incidence of TE and/or TMA (including the time to onset, outcome, treatment state etc.)
3. Treatment state on the occurrence of TE and/or TMA.(including bypassing agents, treatment period, dosage volume etc. of Hemlibra and bypassing agents.)
4. Treatment state on the occurrence of bleeding of Hemlibra and Bypassing agents (including agents name, treatment period, dosage volume etc.)
- The time to onset of ADRs.
- The treatment status and outcome of ADRs.
- Occurrence state of bleeding.
- Annualized Bleeding Rate (ABR).
Observational
Not applicable |
Not applicable |
Male and Female
All patients(Inhibitor hemophilia A) who are scheduled to receive HEMLIBRA at contracted institutions during.
No criteria
100
1st name | Makoto |
Middle name | |
Last name | Nomura |
Chugai Pharmaceutical Co. Ltd.
Safety science Dept.
103-8324
1-1 Nihonbashi-muromachi 2-chome, Chuo-ku Tokyo, Japan
03-3281-6611
nomuramkt@chugai-pharm.co.jp
1st name | Ryousuke |
Middle name | |
Last name | Harada |
Chugai Pharmaceutical Co. Ltd.
Safety science Dept.
103-8324
1-1 Nihonbashi-muromachi 2-chome, Chuo-ku Tokyo, Japan
03-3281-6611
haradarus@chugai-pharm.co.jp
Chugai Pharmaceutical Co. Ltd.
Chugai Pharmaceutical Co. Ltd.
Profit organization
None
None
None
None
NO
2018 | Year | 05 | Month | 21 | Day |
Unpublished
Open public recruiting
2018 | Year | 04 | Month | 17 | Day |
2018 | Year | 05 | Month | 22 | Day |
Adverse events, Patient baseline characteristics, Treatment history, Occurrence state of bleeding, etc.
2018 | Year | 05 | Month | 08 | Day |
2022 | Year | 12 | Month | 28 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037081
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |