UMIN-CTR Clinical Trial

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

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000538
Receipt No. 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

* 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 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
Email 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
Email mohira@hiroshima-u.ac.jp

Sponsor
Institute Department of surgery, division of frontier medical science, programs for biomedical research, Graduate school of biomedical sciences, Hiroshima university
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000655

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.