Unique ID issued by UMIN | UMIN000007919 |
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Receipt number | R000009316 |
Scientific Title | Administration of erythropoietin on telaprevir/PEG-IFN/RBV triple combination therapy in HCV patients with low pre-treatment hemoglobin levels. |
Date of disclosure of the study information | 2012/05/10 |
Last modified on | 2015/05/12 18:28:43 |
Administration of erythropoietin on telaprevir/PEG-IFN/RBV triple combination therapy in HCV patients with low pre-treatment hemoglobin levels.
Administration of erythropoietin on telaprevir/PEG-IFN/RBV triple combination therapy in HCV patients with low pre-treatment hemoglobin levels.
Administration of erythropoietin on telaprevir/PEG-IFN/RBV triple combination therapy in HCV patients with low pre-treatment hemoglobin levels.
Administration of erythropoietin on telaprevir/PEG-IFN/RBV triple combination therapy in HCV patients with low pre-treatment hemoglobin levels.
Japan |
Chronic hepatitis C
Hepato-biliary-pancreatic medicine |
Others
YES
To clarify whether administration of erythropoietin and ITPA genotype affect the treatment response and adverse events in telaprevir/PEG-IFN/RBV triple combination therapy.
Efficacy
Adherence of telaprevir/PEG-IFN/RBV triple combination therapy up to 12 weeks
1) Change of hemoglobin level
2) Differences of treatment efficacy depending on IL28B or ITPA genotypes
3) Correlation between drug adherence of telaprevir/PEG-IFN/RBV and treatment efficacy
4) Ratio of discontinuation and treatment duration of telaprevir/PEG-IFN/RBV
5) Correlation between viral mutation and treatment efficacy
6) Correlation between drug adherence and telaprevir-resistant viral mutation
7) Correlation between telaprevir-resistant viral mutation and plasma concentration of telaprevir
8) Difference of treatment efficacy depending on administration of erythropoietin
Interventional
Parallel
Randomized
Open -no one is blinded
Active
2
Treatment
Medicine | Gene |
Administration of erythropoietin
ITPA genotype
20 | years-old | <= |
70 | years-old | > |
Male and Female
1) Patients over 20 years of age
2) Pre-treatment hemoglobin level is below 13 g/dl
3) HCV patients with serogroup 1 and high viral load
4) Patients with IL28B and ITPA genotypes determined
1) Patients over 70 years of age
2) Patients with liver cirrhosis
3) Patients with hepatocellular carcinoma or other malignancies
4) Patients co-infected with HIV or HBV
5) Patients judged by doctor that participation in the study is improper
40
1st name | |
Middle name | |
Last name | Kei Fujiwara |
Nagoya City University, Graduate School of Medical Sciences
Department of Gastroenterology and Metabolism
1 Kawasumi, Mizuho, Mizuho, Nagoya
052-853-8211
keifuji@med.nagoya-cu.ac.jp
1st name | |
Middle name | |
Last name | Kentaro Matsuura |
Nagoya City University, Graduate School of Medical Sciences
Department of Gastroenterology and Metabolism
1 Kawasumi, Mizuho, Mizuho, Nagoya
052-853-8211
keifuji@med.nagoya-cu.ac.jp
Nagoya City University, Graduate School of Medical Sciences
Department of Virology,
Nagoya City University, Graduate School of Medical Sciences
Self funding
NO
2012 | Year | 05 | Month | 10 | Day |
Unpublished
Completed
2012 | Year | 02 | Month | 06 | Day |
2012 | Year | 05 | Month | 01 | Day |
2014 | Year | 12 | Month | 11 | Day |
2012 | Year | 05 | Month | 09 | Day |
2015 | Year | 05 | Month | 12 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009316
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