Unique ID issued by UMIN | UMIN000034794 |
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Receipt number | R000039679 |
Scientific Title | Therapeutic effect and related factors of glecaprevir/pibrentasvir combination therapy for hepatitis C infected patients |
Date of disclosure of the study information | 2018/11/07 |
Last modified on | 2020/11/08 10:57:50 |
Therapeutic effect and related factors of glecaprevir/pibrentasvir combination therapy for hepatitis C infected patients
Therapeutic effect and related factors of glecaprevir/pibrentasvir combination therapy for hepatitis C infected patients
Therapeutic effect and related factors of glecaprevir/pibrentasvir combination therapy for hepatitis C infected patients
Therapeutic effect and related factors of glecaprevir/pibrentasvir combination therapy for hepatitis C infected patients
Japan |
patients with HCV infection
Hepato-biliary-pancreatic medicine |
Others
NO
To analyze therapeutic effect and related factors of glecaprevir/pibrentasvir combination therapy for HCV patients
Safety,Efficacy
Sustained virological response
1.Safety
2.Factors in patients who failed to antiviral therapy
3.Changes in lipid metabolism
Observational
20 | years-old | <= |
Not applicable |
Male and Female
1)Patients with chronic hepatitis or compensated cirrhosis
2)Child-Pugh Score 5 or 6
3)Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1
4)Adequate functional reserve of major organs
5)Over 20 years old
6)Capable of complying with requirements with respect to visit days, medication, and laboratory tests
7)The patient provides written informed consent before the start of the clinical study
1)History of hypersensitivity to any component of the study drug
2)Receiving contraindicated drugs for Elbasvir/Grazoprevir combined therapy
3)Esophageal varices with the potential to bleed
4)Any of the following diseases within 12 months before enrollment in the clinical study: myocardial infarction, unstable angina, cardiac failure, and cerebrovascular disorder
5)Patients with active hepatocellular carcinoma
6)Patients with brain tumor
7)Patients with active double cancer
8)Human immunodeficiency virus (HIV) or acquired immune deficiency syndrome (AIDS) -related disease
9)Pregnant or nursing
10)Otherwise found by the investigator or subinvestigator to be ineligible as a subject
100
1st name | Noriyuki |
Middle name | |
Last name | Akutsu |
Sapporo Medical University School of Medicine
Department of Gastroenterology and Hepatology
0608543
Minami 1-jo Nishi 16-chome, Chuo-ku, Sapporo, Hokkaido, Japan
011-611-2111
akutsu@sapmed.ac.jp
1st name | Noriyuki |
Middle name | |
Last name | Akutsu |
Sapporo Medical University School of Medicine
Department of Gastroenterology and Hepatology
0608543
Minami 1-jo Nishi 16-chome, Chuo-ku, Sapporo, Hokkaido, Japan
011-611-2111
akutsu@sapmed.ac.jp
Sapporo Medical University School of Medicine
None
Self funding
IRB of Sapporo Medical University School of Medicine
Minami 1-jo Nishi 16-chome, Chuo-ku, Sapporo, Hokkaido, Japan
011-611-2111
ji-rskk@sapmed.ac.jp
NO
札幌医科大学附属病院医学部 消化器内科、手稲渓仁会病院 消化器病センター、
市立釧路総合病院 消化器内科、函館五稜郭病院 消化器内科、
市立小樽病院 消化器内科、市立室蘭総合病院 消化器内科、
帯広協会病院 消化器内科、札幌禎心会病院 消化器内科、
JR札幌病院 内科、天使病院 消化器内科、札幌里塚病院 内科、
済生会小樽病院 消化器内科、札幌外科記念病院内科、
同交会病院 内科、札幌しらかば台病院 消化器内科
2018 | Year | 11 | Month | 07 | Day |
Unpublished
Completed
2017 | Year | 12 | Month | 15 | Day |
2018 | Year | 01 | Month | 11 | Day |
2018 | Year | 01 | Month | 11 | Day |
2019 | Year | 08 | Month | 31 | Day |
Prospective observational study
2018 | Year | 11 | Month | 07 | Day |
2020 | Year | 11 | Month | 08 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039679
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