UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030612 |
|---|---|
| Receipt number | R000034895 |
| Scientific Title | A multi-center clinical trial of tolerance induction using autologous regulatory T cells in liver transplantation |
| Date of disclosure of the study information | 2018/01/01 |
| Last modified on | 2020/01/15 16:46:43 |
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Basic information
Public title
A multi-center clinical trial of tolerance induction using autologous regulatory T cells in liver transplantation
Acronym
Treg multicenter clinical trial
Scientific Title
A multi-center clinical trial of tolerance induction using autologous regulatory T cells in liver transplantation
Scientific Title:Acronym
Treg multicenter clinical trial
Region
| Japan |
Condition
Condition
End-stage liver failure patients eligible for liver transplantation
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To induce tolerance by infusing autologous donor antigen-specific regulatory T cells, generated ex-vivo from peripheral blood mononuclear cells, in living donor liver transplantation.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Immunosuppressive drug free rate at 30-month after liver transplantation
Key secondary outcomes
1.Amount of immunosuppressive drugs at 1, 2, 3, 4 and 5 years after liver transplantation
2.Drug free interval time after complete cessation of immunosuppressive drugs
3.Successful rate of immunosuppressive drug withdrawal at 30-month after liver transplantation by age
4.Safety of autologous regulatory T cell infusion
5.Safety of leukopheresis
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
| Other |
Interventions/Control_1
The liver transplant recipient is given cyclophosphamide (40 mg/kg, iv) on postoperative days (POD) 5, and ex-vivo generated regulatory T cells on POD 13. Postoperative immunosuppression is with conventioal method. The immunosuppressant is reduced to 3/4 daily dose of the twice daily dose at 6 months, which is reduced to 3 times/week, 2 times/ week and 1 time/week every 3 months after confirming normal graft function and liver biopsy. The immunosuppressant is completely discontinued by 18 months after 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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Recipient
1. A case considered to have eligibility for liver transplantation by the specialists (liver transplant surgeons, physicians, anesthesiologists, radiologists, psychiatrists and pathologists) at the associated institutions
2. A case who is approved for liver transplantation by the medical IRB at the associated institutions
3. A patient over 20 years old. Each institute determine the upper limit of age.
4. A patient who receives informed consent and is well-understood for this protocol and given a consent in writing voluntarily
Donor
1. A case considered to have eligibility for liver transplantation donor by the specialists (liver transplant surgeons, physicians, anesthesiologists, radiologists, psychiatrists and pathologists) at the associated institutions
2. A case who is approved for liver transplantation donor by the medical IRB at the associated institutions
3. Platelet >= 100x103/micro L and Hb >= 12.0 g/dL
4. A donor who receives informed consent and is well-understood for this protocol and given a consent in writing voluntarily
Key exclusion criteria
Recipient
1. A person who has no recognition capacity
2. A person who is judged inadequate for the protocol due to the following past history or ongoing infections
1) Bacterial infection such as Treponema pallidum, Neisseria gonorrhea or Mycobacterium tuberculosis
2) Sepsis
3) Malignant diseases (except for hepatocellular carcinoma)
4) Severe metabolic diseases
5) Collagen disease or hematological disorders
6) Transmissible spongiform encephalopathy or dementia
7) A specific hereditary disease or associated familial history
8) Human immunodeficiency virus infection
9) Human T-cell leukemia virus type 1 infection
10) Human parvovirus B19 infection
11) Active infection such as Cytomegalovirus, Epstein-Barr virus or West Nile virus
3. A person
1) with systolic blood pressure under 90 mmHg or over 180 mmHg,
2) with diastolic blood pressure under 50 mmHg or over 100 mmHg
4. A person considered ineligible due to some medical reasons by principal investigator or co-researchers
Donor
1. A donor who has no recognition capacity
2. A donor who is judged inadequate for the protocol due to the following past history or ongoing infections
1) Bacterial infection such as Treponema pallidum, Neisseria gonorrhea or Mycobacterium tuberculosis
2) Sepsis
3) Malignant diseases
4) Severe metabolic diseases
5) Collagen disease or hematological disorders
6) Liver diseases
7) Transmissible spongiform encephalopathy or dementia
8) A specific hereditary disease or associated familial history
9) HBV infection
10) HCV infection
11) Human immunodeficiency virus infection
9) Human T-cell leukemia virus type 1 infection
10) Human parvovirus B19 infection
11) Active infection such as Cytomegalovirus, Epstein-Barr virus or West Nile virus
3. A donor
1) with systolic blood pressure under 90 mmHg or over 180 mmHg,
2) with diastolic blood pressure under 50 mmHg or over 100 mmHg
4. A person considered ineligible due to some medical reasons by principal investigator or co-researchers
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Akinobu |
| Middle name | |
| Last name | Taketomi |
Organization
Hokkaido University Graduate School of Medicine
Division name
Department of Gastroenterological Surgery I
Zip code
060-8648
Address
N-14, W-5, Kita-ku, Sapporo 060-8648, Japan
TEL
011-706-5927
taketomi@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Akinobu |
| Middle name | |
| Last name | Taketomi |
Organization
Hokkaido University Graduate School of Medicine
Division name
Department of Gastroenterological Surgery I
Zip code
060-8648
Address
N-14, W-5, Kita-ku, Sapporo 060-8648, Japan
TEL
011-706-5927
Homepage URL
taketomi@med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development (AMED)
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hokkaido University Hospital
Address
Kita 14, Nishi 5, Kita-ku, Sapporo, Hokkaido
Tel
011-706-7061
https://crmic.huhp.hokudai.ac.jp/page/?content=201
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
| 2018 | Year | 01 | Month | 01 | 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
1
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
Terminated
Date of protocol fixation
| 2018 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 01 | Month | 18 | Day |
Anticipated trial start date
| 2018 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 08 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 12 | Month | 28 | Day |
Last modified on
| 2020 | Year | 01 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034895
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