Unique ID issued by UMIN | UMIN000019801 |
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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 |
Identification of Biomarkers for Prediction of Hepatocellular Carcinoma after Elimination of Hepatitis C Virus by Antiviral Medicine, Harvoni
Identification of Biomarkers for Prediction of Hepatocellular Carcinoma
Identification of Biomarkers for Prediction of Hepatocellular Carcinoma after Elimination of Hepatitis C Virus by Antiviral Medicine, Harvoni
Identification of Biomarkers for Prediction of Hepatocellular Carcinoma
Japan |
Chronic hepaititis due to HCV
Compensated liver cirroshis due to HCV
Medicine in general | Gastroenterology | Hepato-biliary-pancreatic medicine |
Others
YES
Identification of Biomarkers for Prediction of Hepatocellular Carcinoma after eliminating Hepatitis C Virus
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)
Exploratory
Explanatory
Not applicable
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 |
Harvoni 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 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
400
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
NEXT Japan
NO
2015 | Year | 11 | Month | 19 | Day |
Unpublished
Preinitiation
2015 | Year | 11 | Month | 18 | Day |
2015 | Year | 11 | Month | 19 | Day |
2019 | Year | 11 | Month | 30 | Day |
2015 | Year | 11 | Month | 16 | Day |
2015 | Year | 11 | Month | 16 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022879
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