Unique ID issued by UMIN | UMIN000006952 |
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Receipt number | R000007819 |
Scientific Title | A randomised comparison of safety and efficacy of triple therapy for 12 weeks, followed by 12 or 36 additional weeks of peginterferon alfa 2b and ribavirin in HCV patients |
Date of disclosure of the study information | 2011/12/26 |
Last modified on | 2013/12/24 23:07:27 |
A randomised comparison of safety and efficacy of triple therapy for 12 weeks, followed by 12 or 36 additional weeks of peginterferon alfa 2b and ribavirin in HCV patients
Study of 12 or 36 additional weeks of peginterferon alfa 2b and ribavirin
A randomised comparison of safety and efficacy of triple therapy for 12 weeks, followed by 12 or 36 additional weeks of peginterferon alfa 2b and ribavirin in HCV patients
Study of 12 or 36 additional weeks of peginterferon alfa 2b and ribavirin
Japan |
Chronic hepatitis C
Hepato-biliary-pancreatic medicine |
Others
YES
Investigate the efficacy, safety and tolerability of triple therapy for 12 weeks, followed by 12 or 36 additional weeks of peginterferon alfa 2b and ribavirin
Safety,Efficacy
Exploratory
Phase III
sustend virologic response
virologic response at4,8,12,24 ,36,48 weeks
Safety ( moniterd clinical and laboratory evaluation)
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
YES
NO
Institution is not considered as adjustment factor.
NO
Central registration
2
Treatment
Medicine |
telaprevir plus peginterferon alfa-2b/ribavirin for 12 weeks, followed by 12 additional weeks of peginterferon alfa 2b and ribavirin
telaprevir plus peginterferon alfa-2b/ribavirin for 12 weeks, followed by 36 additional weeks of peginterferon alfa 2b and ribavirin
20 | years-old | <= |
70 | years-old | > |
Male and Female
Genotype 1 and high virus load(5 logIU/ml < or=)
IL28BSNP (rs8099917) nonTT
1) Transient response to prior treatment
2) Patients receiving shosaiko-to
3) Autoimmune hepatitis
4) History of hypersensitivity to PEG-IFN alpha-2b and telaprevir
5) History of hypersensitivity to biological products such as vaccine
6) Decompenstated liver cirrhosis
7) HCC, malignat tumor
8) With or with a history of severe psychosis such as severe depression, suicidal ideation or attempt, etc.
9) Pregnant or lactating women and women who may be pregnant
10) Judged by investigator not to be appropriate for inclusion in this study
230
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
kamy4419@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
Hiroshima liver study group
none
Self funding
NO
広島大学病院(広島)、虎の門病院(東京)、札幌厚生病院(北海道)、川上消化器内科クリニック(広島)、市立三次中央病院(広島)、広島赤十字原爆病院(広島)、JA尾道総合病院(広島)、庄原赤十字病院(広島)、済生会呉病院(広島)、県立広島病院(広島)、呉医療センター(広島)、広島記念病院(広島)、広島市立安佐市民病院(広島)、中電病院(広島)、広島鉄道病院(広島)、土谷総合病院(広島)、マツダ病院(広島)、JA広島総合病院(広島)、吉川医院(広島)、東広島医療センター(広島)、呉共済病院(広島)、県立安芸津病院(広島)、中国労災病院(広島)、舛田内科消化器科(広島)、なかむら内科クリニック(広島)、
2011 | Year | 12 | Month | 26 | Day |
Unpublished
Terminated
2011 | Year | 09 | Month | 26 | Day |
2011 | Year | 12 | Month | 01 | Day |
2011 | Year | 12 | Month | 26 | Day |
2013 | Year | 12 | Month | 24 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007819
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