UMIN-CTR Clinical Trial

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
Email	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
Email	yohei@z7.keio.jp

Sponsor
Institute	Keio University Hospital
Institute
Department

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
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 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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026190