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 2020/02/16 16:43:51

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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 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

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

Value
https://center6.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