UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000023502
Receipt No. R000027072
Scientific Title Prognostic factors in patients with primary biliary cirrhosis (PBC) after liver transplantation: a multicenter, prospective stud
Date of disclosure of the study information 2016/08/05
Last modified on 2018/02/05

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Prognostic factors in patients with primary biliary cirrhosis (PBC) after liver transplantation: a multicenter, prospective stud
Acronym A multicenter, prospective study of patients with primary biliary cirrhosis after liver transplantation
Scientific Title Prognostic factors in patients with primary biliary cirrhosis (PBC) after liver transplantation: a multicenter, prospective stud
Scientific Title:Acronym A multicenter, prospective study of patients with primary biliary cirrhosis after liver transplantation
Region
Japan

Condition
Condition primary biliary cholangitis
Classification by specialty
Hepato-biliary-pancreatic medicine Hepato-biliary-pancreatic surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 In patients with PBC after living donor-related liver transplantation, we aim to investigate the association of outcomes and recurrence of PBC with anti-donor specific antibodies or other clinical factors.
Basic objectives2 Others
Basic objectives -Others Liver transplantation is a single therapeutic option for patients with primary biliary cholangitis (PBC) progressing to liver failure. We previously demonstrated that anti-donor specific antibodies (DSA) were associated with outcomes and recurrence of PBC after transplantation in the retrospective study. In this prospective study we ask recipients and donors expecting living donor-related liver transplantation for PBC to participate, and aim to investigate whether DSA are associated with outcomes and recurrence of PBC.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes identification of association between outcomes (mortality and recurrence of PBC) and DSA or other clinical factors
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients with PBC expecting living donor-related liver transplantation, and
1) age >20 years old
2) informed consented with full explanation and understanding on participation
Key exclusion criteria patients judged as inappropriate for participating by principal investigator
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroto Egawa
Organization Tokyo Women's Medical University
Division name Department of Surgery, Institute of Gastroenterology
Zip code
Address 8-1, Kawada-cho, Shinjuku-ku, Tokyo
TEL 03-3353-8111
Email egawa@ige.twmu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Atsushi Tanaka
Organization Teikyo University Schoool of Medicine
Division name Department of Medicine
Zip code
Address 2-11-1, Kaga, Itabashi-ku, Tokyo
TEL 03-3964-1211
Homepage URL
Email a-tanaka@med.teikyo-u.ac.jp

Sponsor
Institute Ministry of Health, Labour and Welfare
Institute
Department

Funding Source
Organization Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization Japanese Governmental office
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 08 Month 05 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 Enrolling by invitation
Date of protocol fixation
2015 Year 12 Month 15 Day
Date of IRB
Anticipated trial start date
2015 Year 12 Month 15 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Samples obtained during observation;
1)Blood will be taken preoperatively from donor and recipient for histocompatibility test, and at 1,3,6,12 months and every year after LT until the end of the study.
2)Liver histology; at operation and postoperative (when abonormal liver test was observed or at regular basis)

Management information
Registered date
2016 Year 08 Month 05 Day
Last modified on
2018 Year 02 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027072

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.