UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058014 |
|---|---|
| Receipt number | R000066305 |
| Scientific Title | Tibsovo Tablets 250 mg General Drug Use-Results Survey (IDH1-mutated acute myeloid leukaemia) |
| Date of disclosure of the study information | 2025/06/02 |
| Last modified on | 2025/05/28 17:54:06 |
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Basic information
Public title
Tibsovo Tablets 250 mg General Drug Use-Results Survey (IDH1-mutated acute myeloid leukaemia)
Acronym
Tibsovo Tablets General Drug Use-Results Survey (IDH1-mutated acute myeloid leukaemia)
Scientific Title
Tibsovo Tablets 250 mg General Drug Use-Results Survey (IDH1-mutated acute myeloid leukaemia)
Scientific Title:Acronym
Tibsovo Tablets General Drug Use-Results Survey (IDH1-mutated acute myeloid leukaemia)
Region
| Japan |
Condition
Condition
IDH1-mutated acute myeloid leukaemia
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study aims to evaluate the following aspects under the actual use conditions of this drug in patients with IDH1-mutated acute myeloid leukaemia (AML) and to promptly identify any issues.
- Primary Endpoint: Incidence of the side effect of Guillain-Barre syndrome
- Secondary Endpoint: Efficacy and safety in patients with IDH1-mutated AML
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Incidence of the side effect of Guillain-Barre syndrome
Key secondary outcomes
Efficacy and safety in patients with IDH1-mutated AML
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with IDH1-mutated acute myeloid leukaemia who received this drug for the first time during the study period and agreed to participate in this study.
Key exclusion criteria
No given consent to participation in the survey.
Target sample size
268
Research contact person
Name of lead principal investigator
| 1st name | Satoshi |
| Middle name | |
| Last name | KAMEYAMA |
Organization
NIHON SERVIER CO., LTD.
Division name
MEDICAL & PATIENT AFFAIRS
Zip code
113-0033
Address
Hongo MK Bldg., 1-28-34, Hongo, Bunkyo-ku, Tokyo, Japan
TEL
07024933214
satoshi.kameyama@servier.com
Public contact
Name of contact person
| 1st name | Daisuke |
| Middle name | |
| Last name | Tanaka |
Organization
NIHON SERVIER CO., LTD.
Division name
MEDICAL & PATIENT AFFAIRS
Zip code
113-0033
Address
Hongo MK Bldg., 1-28-34, Hongo, Bunkyo-ku, Tokyo, Japan
TEL
07075969589
Homepage URL
daisuke.tanaka@servier.com
Sponsor or person
Institute
NIHON SERVIER CO., LTD.
Institute
Department
Personal name
Funding Source
Organization
NIHON SERVIER CO., LTD.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
NIHON SERVIER CO., LTD.
Address
113-0033 Hongo MK Bldg., 1-28-34, Hongo, Bunkyo-ku, Tokyo, Japan
Tel
07024933214
satoshi.kameyama@servier.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 06 | Month | 02 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2025 | Year | 05 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 06 | Month | 02 | Day |
Last follow-up date
| 2031 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The survey will be conducted to be followed GPSP Ministerial Ordinance, relevant regulations and Operating Procedures to ensure the quality of the survey.
Management information
Registered date
| 2025 | Year | 05 | Month | 29 | Day |
Last modified on
| 2025 | Year | 05 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066305
