Unique ID issued by UMIN | UMIN000020911 |
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Receipt number | R000024127 |
Scientific Title | The effects of IFN-free 2D regimen (ombitasvir/paritaprevir/ritonavir) on host immune responses against hepatitis C virus |
Date of disclosure of the study information | 2016/02/06 |
Last modified on | 2016/03/09 16:07:27 |
The effects of IFN-free 2D regimen (ombitasvir/paritaprevir/ritonavir) on host immune responses against hepatitis C virus
The effect of HCV elimination on host immune responces against hepatitis C virus
The effects of IFN-free 2D regimen (ombitasvir/paritaprevir/ritonavir) on host immune responses against hepatitis C virus
The effect of HCV elimination on host immune responces against hepatitis C virus
Japan |
Chronic liver diseases due to infection with genoetype1/serotype 1 hepatitis C virus
Medicine in general | Hepato-biliary-pancreatic medicine |
Others
YES
To investigate whether the AbbVie's 2D therapy has the possibility to restore host immune responses against HCV and to understand the mechanism, we analyze gene expression profiles in peripheral blood mononuclear cells and immunological effects during and after the treatment.
Safety
This is an exploratory study to investigate whether 2D therapy with PTV/r/OBV restores host immune response against HCV via comparing changes in gene expression profiles between patients who achieve SVR vs. patients who do not achieve SVR.
1)To further explore changes in immune response via analyzing the effect on cytokine changes in peripheral blood and analyzing effect at the molecular level
2)Predicion of hepatoma by using age, sex, fibrotic markers (APRI, FIB-4, and Fibro test etc.), fibrotic scoring, and cellular immunity
3)To explore host or viral factors contributing to SVR
Interventional
Single arm
Non-randomized
Open -no one is blinded
Self control
1
Diagnosis
Medicine |
Viekirax, once per day, 2 tablets per once (Paritaprevir 150mg,Ombitasvir 25mg, ritonavir 100mg), for 12 weeks
20 | years-old | <= |
80 | years-old | > |
Male and Female
1)Patients with chronic hapatitis or compensated liver cirrhosis due to HCV infection, and treated by Viekirax
2) HCV is genotype1 or serotype 1
1)Patiens who have had allergy to any ingredients of Viekirax
2)Patienes who are taking any medicines which are on the lists of contraindication for coadministration in the pharmaceutical reference of Viekirax
3)Patients who show moderate-severe hepatic dysfunction (Child-Pugh classification B or C)
4)Patients who have been treated for hepatoma within 6 months before taking Viekrax
200
1st name | |
Middle name | |
Last name | Mizukoshi Eishiro |
Kanazawa University Hospital
Department of Gastroenterology
13-1, Takaramahi, Kanazawa
076-265-2235
eishirom@m-kanazawa.jp
1st name | |
Middle name | |
Last name | Tetsuro Shimakami |
Kanazawa University Hospital
Department of Gastroenterology
13-1, Takaramahi, Kanazawa
076-265-2235
shimakami@m-kanazawa.jp
Kanazawa University Hospital
AbbVie Inc.
Other
NO
2016 | Year | 02 | Month | 06 | Day |
Unpublished
Open public recruiting
2016 | Year | 03 | Month | 05 | Day |
2016 | Year | 03 | Month | 05 | Day |
2016 | Year | 02 | Month | 06 | Day |
2016 | Year | 03 | Month | 09 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024127
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