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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000039476
Receipt No. R000045007
Scientific Title Bavencio Intravenous200 mg Special Drug Use - results Survey (Curatively unresectable or metastatic renal cell carcinoma)
Date of disclosure of the study information 2020/02/13
Last modified on 2020/02/13

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Basic information
Public title Bavencio Intravenous200 mg Special Drug Use - results Survey (Curatively unresectable or metastatic renal cell carcinoma)
Acronym Bavencio Special Drug Use-results Survey (Renal cell carcinoma)
Scientific Title Bavencio Intravenous200 mg Special Drug Use - results Survey (Curatively unresectable or metastatic renal cell carcinoma)
Scientific Title:Acronym Bavencio Special Drug Use-results Survey (Renal cell carcinoma)
Region
Japan

Condition
Condition Curatively unresectable or metastatic renal cell 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 Incidence of all Adverse drug reactions / all Adverse Events related to the Safety Specification
Key secondary outcomes Effectiveness in terms of Best Overall Response and Overall Survival

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 Bavencio for Curatively unresectable or metastatic renal cell carcinoma 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 153-8926
Address Arco Tower 4F, 1-8-1 Shimomeguro, Meguro-ku, Tokyo, Japan
TEL 03-6756-0791
Email hidehiko.momo@merckgroup.com

Public contact
Name of contact person
1st name Yuichi
Middle name
Last name Tanaka
Organization Merck Biopharma Co., Ltd.
Division name PMS Planning & Strategy, Medical Department
Zip code 153-8926
Address Arco Tower 4F, 1-8-1 Shimomeguro, Meguro-ku, Tokyo, Japan
TEL 03-6756-0791
Homepage URL
Email yuichi.tanaka@merckgroup.com

Sponsor
Institute Merck Biopharma Co., Ltd.
Institute
Department

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 Arco Tower 4F, 1-8-1 Shimomeguro, Meguro-ku, Tokyo, Japan
Tel 03-6756-0791
Email yuichi.tanaka@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
2020 Year 02 Month 13 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 Open public recruiting
Date of protocol fixation
2019 Year 12 Month 20 Day
Date of IRB
2019 Year 12 Month 20 Day
Anticipated trial start date
2019 Year 12 Month 20 Day
Last follow-up date
2022 Year 10 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
2020 Year 02 Month 13 Day
Last modified on
2020 Year 02 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045007

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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