Unique ID issued by UMIN | UMIN000019391 |
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Receipt number | R000022430 |
Scientific Title | Study of drug resistance virus in oral agents to genotype 1 chronic hepatitis |
Date of disclosure of the study information | 2015/10/20 |
Last modified on | 2015/10/18 13:23:44 |
Study of drug resistance virus in oral agents to genotype 1 chronic hepatitis
Study of drug resistance virus to genotype 1 chronic hepatitis
Study of drug resistance virus in oral agents to genotype 1 chronic hepatitis
Study of drug resistance virus to genotype 1 chronic hepatitis
Japan |
Genotype 1 chronic hepatitis C
Hepato-biliary-pancreatic medicine |
Others
NO
Recently, direct-acting antiviral agents (DAAs) which specifically effect for HCV virus is developed. Drug resistance virus influence the efficacy of DAAs. The first generation treatment of Daclatasvir/Asunaprevir were available from 2014 in Japan. Drug resistance virus was deeply associated with the efficacy of treatment in Daclatasvir/Asunaprevir treatment. Drug resistance virus is expected to influence the outcome of second generation treatments (ledipasvir/sofosbuvir or ombitasvir/paritaprevir/ritonavir etc.). But it has not been reported on the real world clinical setting in Japan. It is important to clarify the association between second generation DAAs treatments and drug resistance virus.
Safety,Efficacy
The dynamic state of drug resistance virus was studied before pre-treatment and viral breakthrough.
HCV RNA levels were assessed at pre treatment and 2, 4, 8, 12weeks or end of treatment (EOT) and at 12 and 24 weeks after completion of treatment, and routine biochemical and hematological tests were also performed.
Observational
20 | years-old | <= |
85 | years-old | >= |
Male and Female
Eligible patients were 20 to 85years of chronic HCV genotype 1 infection. Patients received the second generation oral agents(ledipasvir/sofosbuvir or ombitasvir/paritaprevir/ritonavir etc.) for 12 weeks.
Patients with decompensated liver disease, coinfection with hepatitis B virus or human immunodeficiency virus, autoimmune hepatitis, primary biliary cirrhosis, hemochromatosis or Wilson's disease were excluded. Patients with uncontrollable hypertension or diabetes mellitus and those with a history of alcohol abuse were also excluded.
200
1st name | |
Middle name | |
Last name | Yoshio Sumida |
Kyoto Prefectural University of Medicine
Department of Molecular Gastroenterology and Hepatology
465, Kajii-chou, Kawaramachi, Kamigyou-ku,Kyoto 602-0841, Japan
075-251-5519
sumida@koto.kpu-m.ac.jp
1st name | |
Middle name | |
Last name | Hideki Fujii |
Kyoto Prefectural University of Medicine
Department of Molecular Gastroenterology and Hepatology
465, Kajii-chou, Kawaramachi, Kamigyou-ku,Kyoto 602-0841, Japan
075-251-5519
http://www.f.kpu-m.ac.jp/k/syokanai/
fuhideki@koto.kpu-m.ac.jp
Kyoto Prefectural University of Medicine, Department of Molecular Gastroenterology and Hepatology
None
Self funding
NO
2015 | Year | 10 | Month | 20 | Day |
Unpublished
Enrolling by invitation
2015 | Year | 09 | Month | 25 | Day |
2015 | Year | 09 | Month | 25 | Day |
Prospective study.Target sample size are 200 cases. We treat the genotype 1 chronic hepatitis with the second generation DAAs as followed by the manufacturer's recommendations. This study have no blind trial or randomization. Patients who are on an outpatients of Kyoto Prefectural University of Medicine or affiliated hospitals in Kinki area and agree with the clinical research are candidate. The dynamic state of drug resistance virus was studied before pre-treatment and viral breakthrough. HCV RNA levels were assessed at pre treatment and 2, 4, 8, 12weeks or end of treatment (EOT) and at 12 and 24 weeks after completion of treatment. Clinical history, clinical background, routine biochemical, hematological tests, were also accumulated and performed.
2015 | Year | 10 | Month | 18 | Day |
2015 | Year | 10 | Month | 18 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022430
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