UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000031098
Receipt number R000035517
Scientific Title Identification of Biomarkers for Prediction of Hepatocellular Carcinoma after Elimination of Hepatitis C Virus by Antiviral Medicines, mavilet
Date of disclosure of the study information 2018/02/02
Last modified on 2018/02/01 15:13:37

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Basic information

Public title

Identification of Biomarkers for Prediction of Hepatocellular Carcinoma after Elimination of Hepatitis C Virus by Antiviral Medicines, mavilet

Acronym

Identification of Biomarkers for Prediction of Hepatocellular Carcinoma

Scientific Title

Identification of Biomarkers for Prediction of Hepatocellular Carcinoma after Elimination of Hepatitis C Virus by Antiviral Medicines, mavilet

Scientific Title:Acronym

Identification of Biomarkers for Prediction of Hepatocellular Carcinoma

Region

Japan


Condition

Condition

Chronic hepaititis due to HCV
Compensated liver cirroshis due to HCV

Classification by specialty

Medicine in general Hepato-biliary-pancreatic medicine

Classification by malignancy

Others

Genomic information

YES


Objectives

Narrative objectives1

Identification of Biomarkers for Prediction of Hepatocellular Carcinoma after Eliminating Hepatitis C Virus with Mavilet

Basic objectives2

Others

Basic objectives -Others

Prediction of HCC using factors such as age, sex, AFP, hepatic fibrosis markers, and hepatic fibrosis scoring methods (including APRI, FIB-4, and Fibro test)

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Identification of New Biomarkers for Prediction of Hepatocellular Carcinoma after Eliminating Hepatitis C Virus

Key secondary outcomes

1)Identification of new biomarkers for prediction of hepatocellular carcinoma after eliminating Hepatitis C Virus
2)Analysis on HCV amino acid/nucleotide sequences (core, NS5A, and NS5B)
3)Analysis on cytokines in peripheral blood
4)Analysis of gene profiling of liver obatained by liver biopsy
5)Analysis of Fibroscan
6)Analysis glucose/lipid metabolism
7)Analysis of gene profiling of peripheral blood lymphocyte
8)Quantification of laminin gamma 2 monomer in serum


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Self control

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Maviret (Glecaprevir 100mg, Pibrentasvir 40 mg) 3T/day, once
Treatment period
1)Chronich haptits C due to genotype 1 and 2:8 weeks, however, if the patients have history of treatment failure with direct-acting antivirals, 12 weeks tretment is possible.
2)Compensated liver cirrhosis due to genotype 1 and 2:12 weeks
3)Chronic haptitis or compensated liver cirrhosis due to other genotypes than 1 and 2: 12 weeks

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

200 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1)Patients with chronic hepatitis or compensated cirrhosis due to HCV infection
2)Patients 20 years of age or older at the time of informed consent

Key exclusion criteria

1)Patients with a history of hypersensitivity to any of the ingredients of Maviret (CONTRAINDICATIONS in the package insert)
2)Patients who are using any of contraindicated co-medications listed in the package insert
3)Patients with severe liver dysfunction (Child-Pugh classification C) (CONTRAINDICATIONS in the package insert)
4)Patients who have received treatment for hepatcellular carcinoma within the past 12 weeks

Target sample size

300


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Tetsuro Shimakami

Organization

Kanazawa University

Division name

Department of Gastroenterology

Zip code


Address

13-1, Takaramachi, Kanazawa, Ishikawa, Japan

TEL

076-265-2244

Email

shimakami@m-kanazawa.jp


Public contact

Name of contact person

1st name
Middle name
Last name Tetsuro Shimakami

Organization

Kanazawa University

Division name

Department of Gastroenterology

Zip code


Address

13-1, Takaramachi, Kanazawa, Ishikawa, Japan

TEL

076-265-2244

Homepage URL


Email

shimakami@m-kanazawa.jp


Sponsor or person

Institute

Kanazawa University

Institute

Department

Personal name



Funding Source

Organization

Self funding

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


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

黒部市民病院       
丸川病院
富山労災病院       
厚生連滑川病院            
富山県立中央病院           
おぎの内科医院   
富山市民病院         
厚生連高岡病院      
市立砺波総合病院        
公立能登総合病院     
恵寿総合病院   
公立羽咋病院             
市立輪島病院
金沢医療センター        
金沢市立病院       
金沢赤十字病院            
石川県済生会金沢病院        
公立松任石川中央病院         
金沢聖霊病院   
能美市立病院             
金沢有松病院       
やわたメディカルセンター 
河北中央病院             
小松ソフィア病院   
小松市民病院        
福井県済生会病院           
市立敦賀病院             
石川県立中央病院   
宇出津総合病院     
福井大学病院       
福井県立病院 
田中内科クリニック


Other administrative information

Date of disclosure of the study information

2018 Year 02 Month 02 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

Open public recruiting

Date of protocol fixation

2017 Year 12 Month 19 Day

Date of IRB


Anticipated trial start date

2018 Year 01 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 02 Month 01 Day

Last modified on

2018 Year 02 Month 01 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035517


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name