UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018224 |
|---|---|
| Receipt number | R000021055 |
| Scientific Title | For Adult blood type incompatibility liver transplant and lymphocyte cross-match cases against humoral rejection A.surgery and anti-blood antibody lowering therapy due to previous anti-Bcell monoclonal antibodies, and plasma exchange B.post-transplantation and hepatic artery in early, portal vein infusion therapy And humoral rejection Y globulin therapy and plasma exchange combination therapy as a treatment for the reaction onset |
| Date of disclosure of the study information | 2015/07/07 |
| Last modified on | 2015/07/07 10:56:37 |
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Basic information
Public title
For Adult blood type incompatibility liver transplant and lymphocyte cross-match cases against humoral rejection
A.surgery and anti-blood antibody lowering therapy due to previous anti-Bcell monoclonal antibodies, and plasma exchange
B.post-transplantation and hepatic artery in early, portal vein infusion therapy
And humoral rejection Y globulin therapy and plasma exchange combination therapy as a treatment for the reaction onset
Acronym
For Adult blood type incompatibility liver transplant and lymphocyte cross-match cases against humoral rejection
Scientific Title
For Adult blood type incompatibility liver transplant and lymphocyte cross-match cases against humoral rejection
A.surgery and anti-blood antibody lowering therapy due to previous anti-Bcell monoclonal antibodies, and plasma exchange
B.post-transplantation and hepatic artery in early, portal vein infusion therapy
And humoral rejection Y globulin therapy and plasma exchange combination therapy as a treatment for the reaction onset
Scientific Title:Acronym
For Adult blood type incompatibility liver transplant and lymphocyte cross-match cases against humoral rejection
Region
| Japan |
Condition
Condition
Living-donor liver transplantation
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Humoral rejection prevention and treatment
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Overall survival
Key secondary outcomes
Complication rate (Clavine-Dindo classification)
Graft survival rate
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Rituximab is used
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
| 18 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Blood type incompatibility transplantation, lymphocyte cross-match cases
In anesthesiology of examination, cases that have been determined to be operative
Key exclusion criteria
Patient consent was not obtained in
this study
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuhisa takeda |
Organization
Yokohama City University Hospital
Division name
Gastroenterological surgery
Zip code
Address
3-9 Fukuura, Kanazawa-ku, Yokohama City, 236-0004, Japan
TEL
045-787-2800
kazutake@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuhisa takeda |
Organization
Yokohama City University Hospital
Division name
Gastroenterological surgery
Zip code
Address
3-9 Fukuura, Kanazawa-ku, Yokohama City, 236-0004, Japan
TEL
045-787-2800
Homepage URL
kazutake@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University Hospital
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
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
| 2015 | Year | 07 | 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
| 2015 | Year | 02 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 02 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 07 | Month | 07 | Day |
Last modified on
| 2015 | Year | 07 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021055
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
