Unique ID issued by UMIN | UMIN000031098 |
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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 |
Identification of Biomarkers for Prediction of Hepatocellular Carcinoma after Elimination of Hepatitis C Virus by Antiviral Medicines, mavilet
Identification of Biomarkers for Prediction of Hepatocellular Carcinoma
Identification of Biomarkers for Prediction of Hepatocellular Carcinoma after Elimination of Hepatitis C Virus by Antiviral Medicines, mavilet
Identification of Biomarkers for Prediction of Hepatocellular 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 Mavilet
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 lymphocyte
8)Quantification of laminin gamma 2 monomer in serum
Interventional
Single arm
Non-randomized
Open -no one is blinded
Self control
1
Treatment
Medicine |
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
200 | years-old | <= |
Not applicable |
Male and Female
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
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
300
1st name | |
Middle name | |
Last name | Tetsuro Shimakami |
Kanazawa University
Department of Gastroenterology
13-1, Takaramachi, Kanazawa, Ishikawa, Japan
076-265-2244
shimakami@m-kanazawa.jp
1st name | |
Middle name | |
Last name | Tetsuro Shimakami |
Kanazawa University
Department of Gastroenterology
13-1, Takaramachi, Kanazawa, Ishikawa, Japan
076-265-2244
shimakami@m-kanazawa.jp
Kanazawa University
Self funding
Self funding
NO
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
2018 | Year | 02 | Month | 02 | Day |
Unpublished
Open public recruiting
2017 | Year | 12 | Month | 19 | Day |
2018 | Year | 01 | Month | 01 | Day |
2018 | Year | 02 | Month | 01 | Day |
2018 | Year | 02 | Month | 01 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035517
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