UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000017329
Receipt number R000020105
Scientific Title Efficacy of antiviral therapy in hepatitis C patients aged 70 years or older: multicenter prospective observational study
Date of disclosure of the study information 2015/05/01
Last modified on 2016/11/01 15:46:40

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Basic information

Public title

Efficacy of antiviral therapy in hepatitis C patients aged 70 years or older: multicenter prospective observational study

Acronym

Efficacy of antiviral therapy in hepatitis C patients aged 70 years or older: multicenter prospective observational study

Scientific Title

Efficacy of antiviral therapy in hepatitis C patients aged 70 years or older: multicenter prospective observational study

Scientific Title:Acronym

Efficacy of antiviral therapy in hepatitis C patients aged 70 years or older: multicenter prospective observational study

Region

Japan


Condition

Condition

Chronic hepatitis C

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

The non-inferiority of IFN-free therapy to IFN-based therapy on risk for hepatocellular carcinoma in patients with SVR

Basic objectives2

Bio-equivalence

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Rates of hepatocarcinogenesis

Key secondary outcomes

Overall survival
Rates of SVR
Rates of interruption of antiviral therapy due to adverse effect


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

70 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Chronic hepatitis C patients aged 70 years or older undergoing antiviral therapy (IFN-free or IFN-based) after 2004.

Key exclusion criteria

Present illness or past history of hepatocellular carcinoma
Positive Hepatitis B viral DNA

Target sample size

516


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Shinji Katsushima

Organization

Kyoto Medical Center, National Hospital Organization

Division name

Department of Gastroenterology

Zip code


Address

1-1, Mukaihata-cho, Fukakusa, Fushimi-ku, Kyoto 612-8555, JAPAN

TEL

81-75-641-9161

Email

skatsush@kyotolan.hosp.go.jp


Public contact

Name of contact person

1st name
Middle name
Last name Shinji Katsushima

Organization

Kyoto Medical Center, National Hospital Organization

Division name

Department of Gastroenterology

Zip code


Address

1-1, Mukaihata-cho, Fukakusa, Fushimi-ku, Kyoto 612-8555, JAPAN

TEL

81-75-641-9161

Homepage URL


Email

skatsush@kyotolan.hosp.go.jp


Sponsor or person

Institute

R24 Liver Conference

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor

Department of Gastroenterology and Hepatology, Kansai Electric Power Hospital
Center for Digestive and Liver Diseases, Nara City Hospital
Department of Gastroenterology, Tenri Hospital
Center for Digestive and Liver Diseases, Japan Commnunity Health care Organization
Hoshigaoka Medical Center
Department of Gastroenterology and Endocrinology, Nara Hospital, Kinki University School of Medicine
Department of Gastroenterology, Yamato Koriyama Hospital
Department of Gastroenterology, Matsushita Memorial Hospital
Department of Gastroenterology and Hepatology, Kyoto Yamashiro General Medical Center
Department of Gastroenterology, Kyoto Kizugawa Hospital
Department of Gastroenterology, Mitsubishi Kyoto Hospital
Department of Gastroenterology and Hepatology, Uji Takeda Hospital

Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

2015 Year 05 Month 01 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

Preinitiation

Date of protocol fixation

2015 Year 02 Month 06 Day

Date of IRB


Anticipated trial start date

2015 Year 05 Month 01 Day

Last follow-up date

2023 Year 12 Month 31 Day

Date of closure to data entry

2024 Year 03 Month 31 Day

Date trial data considered complete

2024 Year 06 Month 30 Day

Date analysis concluded

2024 Year 09 Month 30 Day


Other

Other related information

Comparison between IFN-free and IFN-based therapy in hepatitis C patients: risk for hepatocellular carcinoma.


Management information

Registered date

2015 Year 04 Month 29 Day

Last modified on

2016 Year 11 Month 01 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020105


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name