UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021373 |
|---|---|
| Receipt number | 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 | 2023/12/21 18:31:50 |
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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 | Junko |
| Middle name | |
| Last name | Sakamoto |
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
Junko_Sakamoto@mail.zenyaku.co.jp
Public contact
Name of contact person
| 1st name | Junko |
| Middle name | |
| Last name | Sakamoto |
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
Junko_Sakamoto@mail.zenyaku.co.jp
Sponsor or person
Institute
Zenyaku Kogyo, Co., Ltd.
Institute
Department
Personal name
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
-
-
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
193
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
| 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
| 2022 | Year | 03 | Month | 18 | Day |
Date of closure to data entry
Date trial data considered complete
| 2023 | Year | 08 | Month | 29 | Day |
Date analysis concluded
| 2023 | Year | 08 | Month | 29 | Day |
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
| 2023 | Year | 12 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024649
