Unique ID issued by UMIN | UMIN000028617 |
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Receipt number | R000032746 |
Scientific Title | Comprehensive analysis of iron and mineral-bone metabolism after HCV clearance by daclatasvir and asunaprevir combination therapy in genotype 1 HCV-infected hemodialysis patients |
Date of disclosure of the study information | 2017/08/09 |
Last modified on | 2018/03/05 23:39:35 |
Comprehensive analysis of iron and mineral-bone metabolism after HCV clearance by daclatasvir and asunaprevir combination therapy in genotype 1 HCV-infected hemodialysis patients
Comprehensive analysis of iron and mineral-bone metabolism after HCV clearance by daclatasvir and asunaprevir combination therapy in genotype 1 HCV-infected hemodialysis patients
Comprehensive analysis of iron and mineral-bone metabolism after HCV clearance by daclatasvir and asunaprevir combination therapy in genotype 1 HCV-infected hemodialysis patients
Comprehensive analysis of iron and mineral-bone metabolism after HCV clearance by daclatasvir and asunaprevir combination therapy in genotype 1 HCV-infected hemodialysis patients
Japan |
genotype 1b HCV patients receiving hemodialysis
Hepato-biliary-pancreatic medicine |
Others
NO
we aim at examining the effect on iron and mineral-bone metabolism after HCV clearance by daclatasvir and asunaprevir combination therapy in genotype 1b HCV-infected hemodialysis patients
Safety,Efficacy
To compare erythropoietic resistance index change between pre and post of treatment
To assess Iron metabolism kinetics
To assess mineral-bone metabolism kinetics
To assess antiviral activity, the proportion of subjects who achieve undetectable HCV RNA at post treatment week 12
To assess safety
To assess CLDQ-HCV, KDQOL-SF
Interventional
Single arm
Non-randomized
Open -no one is blinded
Self control
1
Treatment
Medicine |
Patients will orally receive ASV 100 mg per dose twice daily and DCV 60 mg once daily for 24 weeks.
20 | years-old | <= |
Not applicable |
Male and Female
1)20 years old or older
2)Genotype 1b HCV -infected patients receiving hemodialysis
3)Patients who were provided with sufficient explanation before participating in this study and who provided written consent to participate in this study on their own free will.
1)Patients with decompensated cirrhosis
2)Patients complicated with hepatic cancer
3)Other patients whom the chief investigator or a sub-investigators considers inappropriate
60
1st name | |
Middle name | |
Last name | Yoshitaka Arase |
Tokai University School of Medicine
Department of Gastroenterology and Hepatology
shimokasuya 143, Isehara, Kanagawa, Japan
0463-93-1121
arase@tokai-u.jp
1st name | |
Middle name | |
Last name | Yoshitaka Arase |
Tokai University Oiso Hospital
Department of Gastroenterology and Hepatology
Gakkyo 21-1, Oisotyo, Nakagun, Kanagawa, Japan
0463-72-3211
arase@tokai-u.jp
Department of Gastroenterology and Hepatology, Tokai University School of Medicine
Bristol-Myers Squibb
Profit organization
NO
東海大学医学部付属病院
東海大学医学部付属大磯病院
東海大学医学部付属八王子病院
東海大学医学部付属東京病院
帝京大学医学部付属病院
順天堂大学医学部付属順天堂医院
順天堂大学医学部付属練馬病院
医療法人社団 松和会 池上総合病院
2017 | Year | 08 | Month | 09 | Day |
Unpublished
Completed
2017 | Year | 01 | Month | 25 | Day |
2017 | Year | 02 | Month | 01 | Day |
2017 | Year | 08 | Month | 09 | Day |
2018 | Year | 03 | Month | 05 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032746
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