Unique ID issued by UMIN | UMIN000025575 |
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Receipt number | 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 21:53:22 |
Identification of Biomarkers for Prediction of Hepatocellular Carcinoma after Elimination of Hepatitis C Virus by Antiviral Medicines, Elbasvir and Grazoprevir
Identification of Biomarkers for Prediction ofHepatocellular Carcinoma
Identification of Biomarkers for Prediction of Hepatocellular Carcinoma after Elimination of Hepatitis C Virus by Antiviral Medicines, Elbasvir and Grazoprevir
Identification of Biomarkers for Prediction ofHepatocellular Carcinoma
Japan |
Chronic hepaititis due to HCV
Compensated liver cirroshis due to HCV
Medicine in general | Hepato-biliary-pancreatic medicine |
Others
YES
Identification of Biomarkers for Prediction of Hepatocellular Carcinoma after eliminating Hepatitis C Virus with Elbasvir and Grazoprevir
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)
Identification of New Biomarkers for Prediction of Hepatocellular Carcinoma after eliminating Hepatitis C Virus
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
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Elbasvir 50mg 1 tablet once daily for 12 weeks
Grazoprevir 50mg 2tablets once daily for 12 weeks
20 | years-old | <= |
Not applicable |
Male and Female
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
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
100
1st name | |
Middle name | |
Last name | Tetsuro Shimakami |
Kanazawa University
Department of Gastroenterology
13-1, Takaramachi, Kanazawa, Ishikawa, Japan
076-265-2235
shimakami@m-kanazawa.jp
1st name | |
Middle name | |
Last name | Tetsuro Shimakami |
Kanazawa University
Department of Gastroenterology
13-1, Takaramachi, Kanazawa, Ishikawa, Japan
076-265-2235
shimakami@m-kanazawa.jp
Kanazawa University
Self funding
Self funding
NO
2017 | Year | 01 | Month | 10 | Day |
Unpublished
2017 | Year | 01 | Month | 07 | Day |
2017 | Year | 01 | Month | 11 | Day |
2017 | Year | 01 | Month | 07 | Day |
2017 | Year | 01 | Month | 07 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029431
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