UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000538 |
|---|---|
| Receipt number | R000000655 |
| Scientific Title | A randomized clinical trial for evaluating effects of activated donor liver mononuclear cells inoculation on liver transplantation recipients with hepatitis C (HCV). |
| Date of disclosure of the study information | 2007/01/01 |
| Last modified on | 2018/06/12 21:29:49 |
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Basic information
Public title
A randomized clinical trial for evaluating effects of activated donor liver mononuclear cells inoculation on liver transplantation recipients with hepatitis C (HCV).
Acronym
A randomized clinical trial for evaluating effects of Liver mononuclear cells on HCV liver transplantation recipients.
Scientific Title
A randomized clinical trial for evaluating effects of activated donor liver mononuclear cells inoculation on liver transplantation recipients with hepatitis C (HCV).
Scientific Title:Acronym
A randomized clinical trial for evaluating effects of Liver mononuclear cells on HCV liver transplantation recipients.
Region
| Japan |
Condition
Condition
Liver transplantation recipients with HCV
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and toxicity of activated donor liver mononuclear cells inoculation to liver transplantation recipients with HCV.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
5-year survival rate, and SVR
Key secondary outcomes
Adverse events, Postoperative infectious complication rate, Median overall survival
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Participated patients will be randomly divided into two groups. One is cell therapy group and the other is untreated group. Patients in cell therapy group are injected activated donor liver mononuclear cells 3 days after liver transplantation.
Interventions/Control_2
Patients in untreated group are injected placebo without cells.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who are expected to be recipients for living-donor liver transplantation
Patients who have submitted a written informed consent
Patients with hepatitis C
Key exclusion criteria
Symptomatic infectious disease
Fluminant hepatitis
ABO incompatible transplantation
Retransplantation
Decision as ineligible by principal investigators
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hideki Ohdan |
Organization
Graduate school of biomedical sciences, Hiroshima university
Division name
Department of surgery, division of frontier medical science, programs for biomedical research
Zip code
Address
1-2-3 Kasumi, Minami-ku, Hiroshima 734-8551
TEL
082-257-5222
hohdan@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masahiro Ohira |
Organization
Graduate school of biomedical sciences, Hiroshima university
Division name
Department of surgery, division of frontier medical science, programs for biomedical research
Zip code
Address
1-2-3 Kasumi, Minami-ku, Hiroshima 734-8551
TEL
082-257-5222
Homepage URL
mohira@hiroshima-u.ac.jp
Sponsor or person
Institute
Department of surgery, division of frontier medical science, programs for biomedical research, Graduate school of biomedical sciences, Hiroshima university
Institute
Department
Personal name
Funding Source
Organization
Department of surgery, division of frontier medical science, programs for biomedical research, Graduate school of biomedical sciences, Hiroshima 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
| 2007 | 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
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
| 2006 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2006 | Year | 12 | Month | 06 | Day |
Last modified on
| 2018 | Year | 06 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000655
