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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000026117
Receipt No. 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 2020/02/16

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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
Email 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
Email miuma1002@gmail.com

Sponsor
Institute Department of Gastroenterology and Hepatology, Nagasaki University Hospital
Institute
Department

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
Email 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 Enrolling by invitation
Date of protocol fixation
2017 Year 01 Month 04 Day
Date of IRB
Anticipated trial start date
2017 Year 01 Month 11 Day
Last follow-up date
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
2020 Year 02 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029982

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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