Unique ID issued by UMIN | UMIN000015541 |
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Receipt number | R000018056 |
Scientific Title | Bioanalysis of DCV/ASV in old patient((aged 76 years or older)infected with HCV: Pilot Study |
Date of disclosure of the study information | 2014/10/28 |
Last modified on | 2016/10/28 12:23:18 |
Bioanalysis of DCV/ASV in old patient((aged 76 years or older)infected with HCV: Pilot Study
PK study of DCV/ASV in old patient infected with HCV
Bioanalysis of DCV/ASV in old patient((aged 76 years or older)infected with HCV: Pilot Study
PK study of DCV/ASV in old patient infected with HCV
Japan |
Chronic hepatitis C
Hepato-biliary-pancreatic medicine |
Others
NO
To evaluate pharmacokinetic profile of DCV/ASV in old patients infected with HCV.
Pharmacokinetics
Exploratory
Phase II
Caluculated PK parameters such as Cmax, Cmin, Tmax, AUC at 1 week
sustend virologic response and
virologic response at 1,2,3,4weeks
Safety ( moniterd clinical and laboratory evaluation)
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine | Maneuver |
The DCV and ASV level in the blood during DCV/ASV dual treatment will be determined in old patients infected with HCV.
60 | years-old | <= |
90 | years-old | >= |
Male and Female
aged 76 years or older patients infected with genotype 1 HCV
1) Autoimmune hepatitis
2) History of hypersensitivity to DCV and ASV
3) Decompenstated liver cirrhosis
4) HCC, malignat tumor
5) Pregnant or lactating women and women who may be pregnant
6) Judged by investigator not to be appropriate for inclusion in this study
6
1st name | |
Middle name | |
Last name | Kazuaki Chayama |
graduate school of biomedical science, Hiroshima university.
Department and medicine and molecular science
1-2-3 kasumi, minami-ku, Hiroshima 734-8551
082-257-5190
Chayama@hiroshima-u.ac.jp
1st name | |
Middle name | |
Last name | Yoshiiku Kawakami |
graduate school of biomedical science, Hiroshima university
Department and medicine and molecular science
1-2-3 kasumi, minami-ku, Hiroshima 734-8551
082-257-5190
kamy4419@hiroshima-u.ac.jp
graduate school of biomedical science, Hiroshima university
Bristol-Myers-Squibb
Profit organization
NO
広島大学病院
2014 | Year | 10 | Month | 28 | Day |
Published
Completed
2014 | Year | 08 | Month | 18 | Day |
2014 | Year | 10 | Month | 28 | Day |
2014 | Year | 10 | Month | 27 | Day |
2016 | Year | 10 | Month | 28 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018056
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