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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000021373
Receipt No. R000024649
Scientific Title Rituxan injection drug use-results survey in ABO-incompatible liver transplantation recipients
Date of disclosure of the study information 2016/03/07
Last modified on 2020/09/04

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Basic information
Public title Rituxan injection drug use-results survey in ABO-incompatible liver transplantation recipients
Acronym Rituxan injection drug use-results survey in ABO-incompatible liver transplantation
Scientific Title Rituxan injection drug use-results survey in ABO-incompatible liver transplantation recipients
Scientific Title:Acronym Rituxan injection drug use-results survey in ABO-incompatible liver transplantation
Region
Japan

Condition
Condition ABO-incompatible liver transplantation
Classification by specialty
Surgery in general Gastrointestinal surgery Hepato-biliary-pancreatic surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To confirm the safety and effectiveness of Rituxan in ABO-incompatible liver transplantation recipients
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Others
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Adverse drug reaction occurrences
Rejection rate
Key secondary outcomes

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 the patients who have received rituximab for inhibition of antibody mediated rejection in ABO-incompatible liver transplantation
Key exclusion criteria None
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Yoshiyuki
Middle name
Last name Sekizawa
Organization Zenyaku Kogyo, Co., Ltd.
Division name Post-Marketing-Surveillance Pharmacovigilance & Quality Assurance Department
Zip code 112-8650
Address 6-15, Otsuka 5-chome, Bunkyo-ku, Tokyo 112-8650
TEL 03-3946-1136
Email Yoshiyuki_Sekizawa@mail.zenyaku.co.jp

Public contact
Name of contact person
1st name Yoshiyuki
Middle name
Last name Sekizawa
Organization Zenyaku Kogyo, Co., Ltd.
Division name Post-Marketing-Surveillance Pharmacovigilance & Quality Assurance Department
Zip code 112-8650
Address 6-15, Otsuka 5-chome, Bunkyo-ku, Tokyo 112-8650
TEL 03-3946-1136
Homepage URL
Email Yoshiyuki_Sekizawa@mail.zenyaku.co.jp

Sponsor
Institute Zenyaku Kogyo, Co., Ltd.
Institute
Department

Funding Source
Organization Zenyaku Kogyo, Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor Chugai Pharmaceutical Co., Ltd.
Name of secondary funder(s)

IRB Contact (For public release)
Organization -
Address -
Tel -
Email -

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
2016 Year 03 Month 07 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
2016 Year 02 Month 29 Day
Date of IRB
2016 Year 02 Month 29 Day
Anticipated trial start date
2016 Year 02 Month 29 Day
Last follow-up date
2024 Year 01 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Study design: All-case surveillance to include all the patients who receive Rituxan for the additional indication at hospitals in Japan on and after the date of approval of the indication, 29 February 2016.
Measurements: No requirements for laboratory tests to be performed. Measurements obtained through the clinical practice will be evaluated.

Management information
Registered date
2016 Year 03 Month 07 Day
Last modified on
2020 Year 09 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024649

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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