UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000019801
Receipt number R000022879
Scientific Title Identification of Biomarkers for Prediction of Hepatocellular Carcinoma after Elimination of Hepatitis C Virus by Antiviral Medicine, Harvoni
Date of disclosure of the study information 2015/11/19
Last modified on 2015/11/16 15:15:33

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Basic information

Public title

Identification of Biomarkers for Prediction of Hepatocellular Carcinoma after Elimination of Hepatitis C Virus by Antiviral Medicine, Harvoni

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 Medicine, Harvoni

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 Gastroenterology 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

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

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


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 lymphocytes


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Harvoni once daily for 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

20 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)HCV genotype 1/serotype 1
3)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 HARVONI(CONTRAINDICATIONS in the package insert)
2)Patients with severe renal impairment (eGFR less than 30 mL/min/1.73 m2) or those with renal failure requiring dialysis (CONTRAINDICATIONS in the package insert)
3)Patients who are using any of the following medications (Contraindications for Coadministration in the package insert):Rifampicin, carbamazepine, or St. John's wort-containing food
4)Patients with decompensated liver disease (poorly controlled ascites, hepatic encephalopathy, or T-Bil more than or equal to 3.0 mg/dL)
5)Patients who have received treatment for HCC within the past 3 years

Target sample size

400


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

076-265-2235

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

076-265-2235

Homepage URL


Email

shimakami@m-kanazawa.jp


Sponsor or person

Institute

Kanazawa University

Institute

Department

Personal name



Funding Source

Organization

NEXT Japan

Organization

Division

Category of Funding Organization

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



Other administrative information

Date of disclosure of the study information

2015 Year 11 Month 19 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 11 Month 18 Day

Date of IRB


Anticipated trial start date

2015 Year 11 Month 19 Day

Last follow-up date

2019 Year 11 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2015 Year 11 Month 16 Day

Last modified on

2015 Year 11 Month 16 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022879


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name