UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026117 |
|---|---|
| Receipt number | R000029982 |
| Scientific Title | Occult Hepatitis C virus in the liver-transplanted patients received anti-HCV therapy |
| Date of disclosure of the study information | 2017/02/14 |
| Last modified on | 2024/08/20 09:19:57 |
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Basic information
Public title
Occult Hepatitis C virus in the liver-transplanted patients received anti-HCV therapy
Acronym
Occult Hepatitis C virus in the liver-transplanted patients
Scientific Title
Occult Hepatitis C virus in the liver-transplanted patients received anti-HCV therapy
Scientific Title:Acronym
Occult Hepatitis C virus in the liver-transplanted patients
Region
| Japan |
Condition
Condition
Hepatitis C virus infection
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To detect occult HCV infection in the liver tissue and PBMC from the liver-transplanted patients who received anti-HCV therapy
Basic objectives2
Others
Basic objectives -Others
To examine the factors which contribute Occult HCV infection
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To detect occult HCV infection in the liver tissue and PBMC from the liver-transplanted patients who received anti-HCV therapy
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
1. Patients who who will visit as outpatient or be admitted to Nagasaki university hospital.
2. Patients who were re-infected with HCV after liver transplantation or had been received anti-HCV therapy.
3. Patients not youger than 20 years old (at the time of informed consent)
4. Genders do not matter.
5. Patients providing written informed consent with their own will.
Key exclusion criteria
1. Patients who were judged to be inappropriate for this study.
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Kazuhiko |
| Middle name | |
| Last name | Nakao |
Organization
Nagasaki University Hospital
Division name
Department of Gastroenterology and Hepatology
Zip code
852-8501
Address
1-7-1 Sakamoto, Nagasaki
TEL
095-819-7481
kazuhiko@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Satoshi |
| Middle name | |
| Last name | Miuma |
Organization
Nagasaki University Hospital
Division name
Department of Gastroenterology and Hepatology
Zip code
852-8501
Address
1-7-1 Sakamoto, Nagasaki
TEL
095-819-7481
Homepage URL
miuma1002@gmail.com
Sponsor or person
Institute
Department of Gastroenterology and Hepatology, Nagasaki University Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of Gastroenterology and Hepatology, Nagasaki University Hospital
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
Clinincal research center, Nagasaki university hospital
Address
1-7-1 Sakamoto, Nagasaki
Tel
0958197726
gaibushikin@ml.nagasaki-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
| 2017 | Year | 02 | Month | 14 | 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
| 2017 | Year | 01 | Month | 04 | Day |
Date of IRB
| 2016 | Year | 12 | Month | 27 | Day |
Anticipated trial start date
| 2017 | Year | 01 | Month | 11 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Not particular
Management information
Registered date
| 2017 | Year | 02 | Month | 13 | Day |
Last modified on
| 2024 | Year | 08 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029982
