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 2024/02/19 10:12:51

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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

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 Taito
Middle name
Last name Ito

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

03-6756-0805

Homepage URL


Email

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

Arco Tower 4F, 1-8-1 Shimomeguro, Meguro-ku, Tokyo, Japan

Tel

03-6756-0805

Email

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

No longer recruiting

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

2024 Year 02 Month 19 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049482


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name