UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008754 |
|---|---|
| Receipt number | R000008281 |
| Scientific Title | An open-label study of the effects of intraoperative double filtration plasmapheresis and adoptive immunotherapy with liver allograft derived lymphocytes combination therapy for hepatitis C recurrence after living donor liver transplantation |
| Date of disclosure of the study information | 2012/08/23 |
| Last modified on | 2016/02/29 18:52:08 |
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Basic information
Public title
An open-label study of the effects of intraoperative double filtration plasmapheresis and adoptive immunotherapy with liver allograft derived lymphocytes combination therapy for hepatitis C recurrence after living donor liver transplantation
Acronym
An open-label study of the effects of intraoperative double filtration plasmapheresis and adoptive immunotherapy with liver allograft derived lymphocytes combination therapy for hepatitis C recurrence after living donor liver transplantation
Scientific Title
An open-label study of the effects of intraoperative double filtration plasmapheresis and adoptive immunotherapy with liver allograft derived lymphocytes combination therapy for hepatitis C recurrence after living donor liver transplantation
Scientific Title:Acronym
An open-label study of the effects of intraoperative double filtration plasmapheresis and adoptive immunotherapy with liver allograft derived lymphocytes combination therapy for hepatitis C recurrence after living donor liver transplantation
Region
| Japan |
Condition
Condition
chronic hepatitis C
Classification by specialty
| Hepato-biliary-pancreatic medicine | Nephrology | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
A combination therapy of intraoperative DFPP and adoptive immunotherapy with liver allograft derived lymphocytes are administered to HCV positive liver transplantation recipients with cirrhois. The aim of the study is to investigate the safety, immunological responses and anti hepatitis C virus activity.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I,II
Assessment
Primary outcomes
Evaluation of antivirus activity (recurrence rate of HCV RNA) of DFPP and adoptive immunotherapy combination therapy
Key secondary outcomes
1.Evaluation of virus reduction effect by DFPP and adoptive immunotherapy combination therapy
2.Adverse effects of DFPP and adoptive immunotherapy combination therapy
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
1)DFPP therapy
Transplant recipients receive DFPP therapy 3 days before and during living donor liver transplantation (for 4 hours and 10 hours, respectively) to remove hepatitis C virus.
2)Adoptive immunotherapy
Patients are intravenously injected 3 days after liver transplantation with liver allograft derived lymphocytes treated with IL-2 and the CD3-specific mAb.
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
The subjects must be satisfactory the following conditions.
1)Patients must consent to adoptive immunotherapy with liver allograft derived lymphocytes
2)Patients must have HCV liver cirrhosis for which liver transplantation is best indicated.
3)Patients must be equal to or more than 20 years old.
4)Written informed consent must be obtained from patients.
Key exclusion criteria
The following patients must be excluded.
1)Recipients with fluminant hepatitis
2)ABO blood type incompatible recipients
3)Recipients of re-transplantation
4)Recipients of deceased donor liver transplantation
5)Patients with the past history of severe shock reactions to any therapy using extracorporeal circulation.
6)Patients who have un-controlable heart disease
7)Patients who are participated in other clinical study within 3 months.
8)Patients who are during pregnancy, lactation expectant, and desiring future fertility.
9)Patients who are judged inappropriate for the clinical trial by doctors.
10)Patients with the past history of severe allergic reactions to nafamostat mesilate.
Target sample size
6
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hideki Ohdan |
Organization
HIroshima University
Division name
Hiroshima University Hospital, Department of surgery
Zip code
Address
1-2-3, Kasumi, Minami-ku, Hiroshima, Japan
TEL
082-257-5222
hohdan@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takashi Onoe |
Organization
Hiroshima University
Division name
Hiroshima University Hospital, Department of surgery
Zip code
Address
1-2-3, Kasumi, Minami-ku, Hiroshima, Japan
TEL
082-257-5222
Homepage URL
tonoemd@gmail.com
Sponsor or person
Institute
Hiroshima University Hospital, Department of surgery
Institute
Department
Personal name
Funding Source
Organization
Hiroshima University Hospital, Department of surgery
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
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
| 2012 | Year | 08 | Month | 23 | 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
| 2012 | Year | 01 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2016 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2016 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2016 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 08 | Month | 23 | Day |
Last modified on
| 2016 | Year | 02 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008281
