UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022897 |
|---|---|
| Receipt number | R000026190 |
| Scientific Title | Rituximab induction for liver transplantation to prevent recurrence of primary sclerosing cholangitis |
| Date of disclosure of the study information | 2016/07/15 |
| Last modified on | 2019/07/29 12:46:06 |
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Basic information
Public title
Rituximab induction for liver transplantation to prevent recurrence of primary sclerosing cholangitis
Acronym
Rituximab induction for liver transplantation to prevent recurrence of primary sclerosing cholangitis
Scientific Title
Rituximab induction for liver transplantation to prevent recurrence of primary sclerosing cholangitis
Scientific Title:Acronym
Rituximab induction for liver transplantation to prevent recurrence of primary sclerosing cholangitis
Region
| Japan |
Condition
Condition
Primary sclerosing cholangitis
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The only curative treatment for advanced primary sclerosing cholangitis is liver transplantation, however the rate of recurrence after liver transplantation is high. The aim of the study is to assess the efficacy of rituximab to prevent recurrence of PSC.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The rate of recurrence of PSC after liver transplantation, and recurrence free liver graft survival
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
RItuximab induction for liver transplantation
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
| 2 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients have to meet the diagnostic criteria of PSC,
Age range 2>, <65
indicated for liver transplantation,
having a living donor with autonomy
Key exclusion criteria
Re-trenaplantation
Deceased donor transplantation,
Domino Transplantation
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ken Hoshino |
Organization
Keio University Hospital
Division name
Department of Pediatric Surgery
Zip code
Address
35 Shinanomachi Shinjuku-ku Tokyo
TEL
03-3353-1211
hoshino@z7.keio.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yohei Yamada |
Organization
Keio University Hospital
Division name
Department of Pediatric Surgery
Zip code
Address
35 Shinanomachi Shinjuku-ku Tokyo
TEL
03-3353-1211
Homepage URL
yohei@z7.keio.jp
Sponsor or person
Institute
Keio University Hospital
Institute
Department
Personal name
Funding Source
Organization
Keio University
Organization
Division
Category of Funding Organization
Self funding
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
| 2016 | Year | 07 | Month | 15 | 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
Completed
Date of protocol fixation
| 2016 | Year | 07 | Month | 15 | Day |
Date of IRB
| 2016 | Year | 09 | Month | 27 | Day |
Anticipated trial start date
| 2016 | Year | 07 | Month | 15 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 06 | Month | 27 | Day |
Last modified on
| 2019 | Year | 07 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026190
