Unique ID issued by UMIN | UMIN000007912 |
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Receipt number | R000009320 |
Scientific Title | Telaprevir therapy in Japanese patients infected with HCV |
Date of disclosure of the study information | 2012/05/08 |
Last modified on | 2017/11/13 18:50:27 |
Telaprevir therapy in Japanese patients infected with HCV
Teraprevir in Japanese CH-C
Telaprevir therapy in Japanese patients infected with HCV
Teraprevir in Japanese CH-C
Japan |
Chronic hepatitis C patients
Hepato-biliary-pancreatic medicine |
Others
YES
To examine the safety and efficacy in Telaprevir therapy in Japanese patients infected with hepatitis C virus (HCV)
Safety,Efficacy
Exploratory
Pragmatic
Not applicable
Anti-viral effects against HCV
1) Association between IL28SNP and treatment response
2) Treatment response and HCV RNA dynamics
3) HCV genome and treatment response
Observational
20 | years-old | <= |
Not applicable |
Male and Female
HCV genotype 1 (subtype 1a or 1b) infected patients
1) Hemoglobin <12g/dl, Neutrophil < 1500/mm3, or Platelet count <100000/mm3
2) Drug allergy to telaprevir, interferon, ribavirin or nucleoside analogues
3) Past-history of dermatological reaction of teraprevir
4) Pregnant women, etc.
5) Women cannot prevent conception.
6) Men cannot prevent conception.
7) Severe heart diseases
8) Abnormal hemoglobinemia
9) Severe renal dysfunction
10) Uncontrolable mental illness
11) Severe liver diseases
12) Uncontrolable autoimmune diseases
13) Past-history of hypersensitivity against vaccination, etc.
14) Patients take prohibited drugs, which interacts with telaprevir.
15) Doctors judged patients as inappropriate persons in this trial
200
1st name | |
Middle name | |
Last name | Osamu Yokosuka, M.D. |
Chiba University, Graduate School of Medicine
Department of Gastroenterology and Nephrology
1-8-1 Inohana, Chuo-ku, Chiba, Japan (260-8677)
+81-43-226-2083
kandat-cib@umin.ac.jp
1st name | |
Middle name | |
Last name | Tatsuo Kanda, M.D. |
Chiba University, Graduate School of Medicine
Department of Gastroenterology and Nephrology
1-8-1 Inohana, Chuo-ku, Chiba, Japan (260-8677)
+81-43-226-2083
kandat-cib@umin.ac.jp
Chiba University, Graduate School of Medicine
Chiba University, Graduate School of Medicine
Other
NO
Chiba University Hospital (Chiba, JPN), Kikkoman General Hospital (Chiba, JPN)
千葉大学医学部附属病院(千葉県)、キッコーマン総合病院(千葉県)
2012 | Year | 05 | Month | 08 | Day |
Unpublished
Terminated
2012 | Year | 03 | Month | 24 | Day |
2012 | Year | 05 | Month | 01 | Day |
2014 | Year | 04 | Month | 30 | Day |
2014 | Year | 04 | Month | 30 | Day |
In future, we will perform the observation study.
2012 | Year | 05 | Month | 08 | Day |
2017 | Year | 11 | Month | 13 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009320
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