UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043435 |
|---|---|
| Receipt number | R000049482 |
| Scientific Title | Bavencio Intravenous 200 mg Special Drug Use results Survey (Maintenance following chemotherapy treatment in curatively unresectable urothelial carcinoma) |
| Date of disclosure of the study information | 2021/02/25 |
| Last modified on | 2025/09/24 16:40:31 |
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Basic information
Public title
Bavencio Intravenous 200 mg Special Drug Use results Survey
(Maintenance following chemotherapy treatment in curatively unresectable urothelial carcinoma)
Acronym
Bavencio Special Drug Use-results Survey (urothelial carcinoma)
Scientific Title
Bavencio Intravenous 200 mg Special Drug Use results Survey
(Maintenance following chemotherapy treatment in curatively unresectable urothelial carcinoma)
Scientific Title:Acronym
Bavencio Special Drug Use-results Survey (urothelial carcinoma)
Region
| Japan |
Condition
Condition
Maintenance following chemotherapy treatment in curatively unresectable urothelial carcinoma
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Survey safety and effectiveness of Bavencio Intravenous 200 mg in clinical practice
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The safety profile of Bavencio Intravenous 200 mg in clinical practice is to be further characterized, by estimating the incidence of events listed as safety specifications, Urinary tract infection and Hematuria in this surveillance study.
Key secondary outcomes
To investigate the effectiveness of Bavencio Intravenous 200 mg in patients with Maintenance following chemotherapy treatment in curatively unresectable urothelial carcinoma in terms of time to treatment failure(TTF), time to first subsequent therapy (TFST) and overall survival (OS) in clinical practice.
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
All patients who received at least one dose of this drug during the enrollment period.
Key exclusion criteria
None
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | Hidehiko |
| Middle name | |
| Last name | Momo |
Organization
Merck Biopharma Co., Ltd.
Division name
PMS Planning & Strategy, Medical Department
Zip code
106-0041
Address
Azabudai Hills Mori JP 26F, 1-3-1 Azabudai, Minato-ku, Tokyo, Japan
TEL
03-6756-0791
hidehiko.momo@merckgroup.com
Public contact
Name of contact person
| 1st name | Taito |
| Middle name | |
| Last name | Ito |
Organization
Merck Biopharma Co., Ltd.
Division name
PMS Planning & Strategy, Medical Department
Zip code
106-0041
Address
Azabudai Hills Mori JP 26F, 1-3-1 Azabudai, Minato-ku, Tokyo, Japan
TEL
03-6756-0805
Homepage URL
taito.ito@merckgroup.com
Sponsor or person
Institute
Merck Biopharma Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Merck Biopharma 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
Merck Biopharma Co., Ltd.
Address
Azabudai Hills Mori JP 26F, 1-3-1 Azabudai, Minato-ku, Tokyo, Japan
Tel
03-6756-0805
taito.ito@merckgroup.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
| 2021 | Year | 02 | Month | 25 | 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
465
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
Completed
Date of protocol fixation
| 2021 | Year | 02 | Month | 24 | Day |
Date of IRB
| 2021 | Year | 02 | Month | 24 | Day |
Anticipated trial start date
| 2021 | Year | 02 | Month | 24 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Special Drug Use-Results Survey according to the GPSP ordinance
Management information
Registered date
| 2021 | Year | 02 | Month | 25 | Day |
Last modified on
| 2025 | Year | 09 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049482
