UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023502 |
|---|---|
| Receipt number | 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 | 2020/08/08 12:43:52 |
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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 | Hiroto |
| Middle name | |
| Last name | Egawa |
Organization
Tokyo Women's Medical University
Division name
Department of Surgery, Institute of Gastroenterology
Zip code
162-8666
Address
8-1, Kawada-cho, Shinjuku-ku, Tokyo
TEL
03-3353-8111
egawa@ige.twmu.ac.jp
Public contact
Name of contact person
| 1st name | ATtsushi |
| Middle name | |
| Last name | Tanaka |
Organization
Teikyo University Schoool of Medicine
Division name
Department of Medicine
Zip code
173-8605
Address
2-11-1, Kaga, Itabashi-ku, Tokyo
TEL
03-3964-1211
Homepage URL
a-tanaka@med.teikyo-u.ac.jp
Sponsor or person
Institute
Ministry of Health, Labour and Welfare
Institute
Department
Personal name
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
Teikyo University School of Medicine
Address
2-11-1,Kaga, Itabashi-ku, Tokyo
Tel
03-3964-1211
turb-office@teikyo-u.ac.jp
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
| 2015 | Year | 12 | Month | 15 | Day |
Anticipated trial start date
| 2015 | Year | 12 | Month | 15 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
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
| 2020 | Year | 08 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027072
| 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 |
