Unique ID issued by UMIN | UMIN000007313 |
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Receipt number | R000008617 |
Scientific Title | Non-inferiority study of telaprevir dose reduction regimen on telaprevir with pegylated interferon and ribavirin therapy for treatment-naive patients with chronic hepatitis C genotype 1; prospective randomized controlled, multicenter trial |
Date of disclosure of the study information | 2012/02/16 |
Last modified on | 2017/07/25 13:41:06 |
Non-inferiority study of telaprevir dose reduction regimen on telaprevir with pegylated interferon and ribavirin therapy for treatment-naive patients with chronic hepatitis C genotype 1; prospective randomized controlled, multicenter trial
Trial comparing treatment efficacy of telaprevir dose reduction regimen with that of telaprevir standard dose regimen on telaprevir with pegylated interferon and ribavirin therapy for treatment-naive patients with chronic hepatitis C genotype 1
Non-inferiority study of telaprevir dose reduction regimen on telaprevir with pegylated interferon and ribavirin therapy for treatment-naive patients with chronic hepatitis C genotype 1; prospective randomized controlled, multicenter trial
Trial comparing treatment efficacy of telaprevir dose reduction regimen with that of telaprevir standard dose regimen on telaprevir with pegylated interferon and ribavirin therapy for treatment-naive patients with chronic hepatitis C genotype 1
Japan |
Chronic hepatitis C
Hepato-biliary-pancreatic medicine |
Others
NO
Comparing treatment efficacy of telaprevir dose reduction regimen with that of telaprevir standard dose regimen on a telaprevir with pegylated interferon and ribavirin therapy for treatment-naive patients with chronic hepatitis C genotype 1
Safety,Efficacy
Confirmatory
Pragmatic
Not applicable
-Sustained virological response rate; the rate of undetectable HCV RNA at end of treatment and at 24 weeks after completion of treatment
-Early virologic response; the rate of undetectable HCV RNA at 12 weeks of treatment
-End of treatment virologic response rate; the rate of undetectable HCV RNA at end of treatment
-The rate of patients without treatment discontinuation due to adverse event
-The rate of adverse events
-Drug adherence
-Transition of quality of life
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Dose comparison
NO
NO
Institution is not considered as adjustment factor.
NO
Central registration
2
Treatment
Medicine |
<Telaprevir standard dose regimen>
Telaprevir: 2250mg/day p.o., 12weeks
Pegylated interferon alpha 2b: 1.5mcg/kg/week i.s., 24weeks
Ribavirin: Body weight; less than 60kg, 600mg/day p.o., 24weeks, 60kg - 80kg, 800mg/day p.o., 24 weeks, more than 80kg, 1000mg/day p.o., 24weeks
<Telaprevir dose reduction regimen>
Telaprevir: 1500mg/day p.o., 12weeks
Pegylated interferon alpha 2b: 1.5mcg/kg/week i.s., 24weeks
Ribavirin: Body weight; less than 60kg, 600mg/day p.o., 24weeks, 60kg - 80kg, 800mg/day p.o., 24 weeks, more than 80kg, 1000mg/day p.o., 24weeks
20 | years-old | <= |
Not applicable |
Male and Female
1) Patients over 20 years old
2) Patients with chronic infection with hepatitis C virus genotype 1 and more than 5 log IU/ml
3) Patients without previous history of pegylated interferon plus ribavirin therapy
1) Patients with co-infection with hepatitis B virus
2) Patients with co-infection with human immunodeficiency virus
3) Patients with alcoholic liver disorder or autoimmune hepatitis
4) Patients with uncompensated cirrhosis or hepatic failure
5) Patients with multiple organ failure or immunological deficiency
6) Patients with severe depression or past history of psychiatric disorder
7) Patients with chronic renal failure
8) Patients in pregnancy or lactating or patients who expect to become pregnant
9) Patients whose hemoglobin levels are less than 12 g/dL
10) Patients whose platelet counts are less than 15,000 /microL
11) Patients whose neutrophil counts are less than 1,500 /microL
12) Patients whom investigator disqualified
280
1st name | |
Middle name | |
Last name | Tetsuo Takehara |
Osaka University Graduate School of Medicine
Department of Gastroenterology and Hepatology
2-2 ,Yamadaooka, Suita, Osaka, Japan
06-6879-3621
takehara@gh.med.osaka-u.ac.jp
1st name | |
Middle name | |
Last name | Naoki Hiramatsu |
Osaka University Graduate School of Medicine
Department of Gastroenterology and Hepatology
2-2, Yamadaooka, Suita, Osaka, Japan
06-6879-3621
hiramatsu@gh.med.osaka-u.ac.jp
Department of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine
Department of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine
Self funding
NO
大阪大学医学部附属病院(大阪府)
国立病院機構大阪医療センター (大阪府)
国立病院機構大阪南医療センター (大阪府)
国立病院機構南和歌山医療センター (和歌山県)
大阪労災病院 (大阪府)
関西労災病院 (兵庫県)
大阪警察病院 (大阪府)
大阪府立成人病センター (大阪府)
大阪府立急性期・総合医療センター (大阪府)
公立学校共済組合近畿中央病院 (兵庫県)
国家公務員共済組合連合会大手前病院 (大阪府)
大阪厚生年金病院 (大阪府)
県立西宮病院 (兵庫県)
箕面市立病院 (大阪府)
市立池田病院 (大阪府)
市立伊丹病院 (大阪府)
市立豊中病院 (大阪府)
市立吹田市民病院 (大阪府)
市立芦屋病院 (兵庫県)
西宮市立中央病院 (兵庫県)
八尾市立病院 (大阪府)
東大阪市立総合病院 (大阪府)
住友病院 (大阪府)
NTT西日本大阪病院 (大阪府)
大阪府済生会千里病院 (大阪府)
加納総合病院 (大阪府)
明和病院 (兵庫県)
大阪回生病院 (大阪府)
笹生病院 (兵庫県)
2012 | Year | 02 | Month | 16 | Day |
Published
Completed
2011 | Year | 02 | Month | 10 | Day |
2012 | Year | 03 | Month | 01 | Day |
2017 | Year | 12 | Month | 01 | Day |
2017 | Year | 12 | Month | 01 | Day |
2017 | Year | 12 | Month | 01 | Day |
2018 | Year | 06 | Month | 01 | Day |
2012 | Year | 02 | Month | 16 | Day |
2017 | Year | 07 | Month | 25 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008617
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