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Name:
UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000025575
Receipt No. R000029431
Scientific Title Identification of Biomarkers for Prediction of Hepatocellular Carcinoma after Elimination of Hepatitis C Virus by Antiviral Medicines, Elbasvir and Grazoprevir
Date of disclosure of the study information 2017/01/10
Last modified on 2017/01/07

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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, Elbasvir and Grazoprevir
Acronym Identification of Biomarkers for Prediction ofHepatocellular Carcinoma
Scientific Title Identification of Biomarkers for Prediction of Hepatocellular Carcinoma after Elimination of Hepatitis C Virus by Antiviral Medicines, Elbasvir and Grazoprevir
Scientific Title:Acronym Identification of Biomarkers for Prediction ofHepatocellular 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 Elbasvir and Grazoprevir
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 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 Elbasvir 50mg 1 tablet once daily for 12 weeks
Grazoprevir 50mg 2tablets 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 Elbasvir/Grazoprevir(CONTRAINDICATIONS in the package insert)
2)Patients who are using any of contraindicated co-medications listed in the package insert
4)Patients with moderate or severe liver dysfunction (Child-Pugh classification B or C)
5)Patients who have received treatment for HCC within the past 24 weeks
Target sample size 100

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
Institute Kanazawa University
Institute
Department

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

Other administrative information
Date of disclosure of the study information
2017 Year 01 Month 10 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
Date of protocol fixation
2017 Year 01 Month 07 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

Management information
Registered date
2017 Year 01 Month 07 Day
Last modified on
2017 Year 01 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029431

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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