Unique ID issued by UMIN | UMIN000030599 |
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Receipt number | R000034941 |
Scientific Title | Prospective study of anti-HCV therapy with pan-genotype direct acting anti-viral agents for patients with chronic liver diseases |
Date of disclosure of the study information | 2018/01/31 |
Last modified on | 2023/04/25 09:30:14 |
Prospective study of anti-HCV therapy with pan-genotype direct acting anti-viral agents for patients with chronic liver diseases
Study of pan-genotype anti-HCV therapy
Prospective study of anti-HCV therapy with pan-genotype direct acting anti-viral agents for patients with chronic liver diseases
Study of pan-genotype anti-HCV therapy
Japan |
Chronic liver disease type C
Hepato-biliary-pancreatic medicine |
Others
NO
Evaluation for anti-viral effect and safety of pan-genotype DAA in patients with chronic liver disease type C
Safety,Efficacy
Sustained viral response at post-treatment 12-week (SVR12)
HCV RNA at end-of-treatment and at post-treatment 24-week (SVR24)
Liver function test after treatment
Adverse events
Observational
20 | years-old | <= |
Not applicable |
Male and Female
Patients with chronic liver disease related HCV infection
1) Active malignant tumor including liver cancer
2) Decompensated hepatic cirrhosis
3) Prohibition of per oral drugs
4) Medication contraindication drugs to pan-genotype DAAs
5) Allergy to pan-genotype DAA
6) Unsuitable condition to the present study
500
1st name | Akihiro |
Middle name | |
Last name | Tamori |
Osaka City University
Department of Hepatology
5458585
1-4-3, Asahimachi, Abeno-ku, Osaka
06-6645-3905
atamori@med.osaka-cu.ac.jp
1st name | Akihiro |
Middle name | |
Last name | Tamori |
Osaka City University
Department of Hepatology
5458585
1-4-3, Asahimachi, Abeno-ku, Osaka
06-6645-3905
atamori@med.osaka-cu.ac.jp
Department of Hepatology, Osaka City University Graduate School of Medicine
Department of Hepatology, Osaka City University Graduate School of Medicine
Self funding
Tokyo University, Yamaguchi University, Osaka University, Osaka Rosai Hospital, Okayama City General Medical Center, Okayama University, Tokushima University, Kagawa Prefectural Central Hospital, Kurume University, Tokai University, Chiba University, The Research Center for Hepatitis and Immunology, National Center for Global Health and Medicine
The ethical committee, Osaka City University Graduate School of Medicine
1-4-3, Asahimachi, Abeno-ku, Osaka
06-6645-3456
ethics@med.osaka-cu.ac.jp
NO
東京大学医科学研究所先端医療研究センター感染症分野、山口大学臨床検査・腫瘍学講座、大阪大学機能診断科学、大阪労災病院消化器内科、岡山市立市民病院消化器内科、岡山大学保健管理センター、徳島大学消化器内科、香川県立中央病院肝臓内科、久留米大学超音波診断センター消化器内科、東海大学消化器内科、三重大学消化器内科、千葉大学消化器内科、国立国際医療研究センター肝炎・免疫センター
2018 | Year | 01 | Month | 31 | Day |
doi: 10.1111/hepr.13410
Partially published
doi: 10.1111/hepr.13410
423
Glecaprevir + pibrentasvir had a remarkable anti-HCV effect in GT-1 and GT-2 patients, but not in GT-3b patients.
Although this therapy was reasonably safe, it is necessary to carefully consider elderly and dropout patients.
2022 | Year | 07 | Month | 01 | Day |
2019 | Year | 12 | Month | 01 | Day |
A total of 423 patients infected with HCV who started treatment at eight different centers in Japan were enrolled in thestudy.
Prospective study
Four of seven patients who discontinued treatment due to severe adverse effects were more than 75 years old.
Glecaprevir + pibrentasvir had a remarkable anti-HCV effect in GT-1 and GT-2 patients, but not in GT-3b patients.
No plan
Completed
2017 | Year | 10 | Month | 30 | Day |
2017 | Year | 12 | Month | 22 | Day |
2017 | Year | 12 | Month | 22 | Day |
2022 | Year | 01 | Month | 21 | Day |
2022 | Year | 01 | Month | 21 | Day |
2022 | Year | 01 | Month | 21 | Day |
2022 | Year | 12 | Month | 31 | Day |
Past history of anti-HCV therapy, and HCC therapy.
Progression of hepatic cirrhosis, HCV genotype.
At baseline; HCV RNA, Plt, AST, ALT, Alb, T. Bil, PT, AFP, Cre, BUN, M2BPGi, type-IV collagen.
End of treatment and after treatment 12-week and 24-week; HCV RNA, Plt, AST, ALT, Alb, T. Bil, PT, AFP, M2BPGi.
2017 | Year | 12 | Month | 27 | Day |
2023 | Year | 04 | Month | 25 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034941
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