UMIN-CTR Clinical Trial

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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