Unique ID issued by UMIN | UMIN000003976 |
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Receipt number | R000004793 |
Scientific Title | Prospective and Retrospective Multicenter Cohort Study of Patients With Chronic Hepatitis C Treated by Peginterferon Alfa-2b Plus Ribavirin |
Date of disclosure of the study information | 2010/08/01 |
Last modified on | 2023/02/13 19:21:49 |
Prospective and Retrospective Multicenter Cohort Study of Patients With Chronic Hepatitis C Treated by Peginterferon Alfa-2b Plus Ribavirin
Prospective and Retrospective Multicenter Cohort Study of Patients With Chronic Hepatitis C Treated by Peginterferon Alfa-2b Plus Ribavirin
Prospective and Retrospective Multicenter Cohort Study of Patients With Chronic Hepatitis C Treated by Peginterferon Alfa-2b Plus Ribavirin
Prospective and Retrospective Multicenter Cohort Study of Patients With Chronic Hepatitis C Treated by Peginterferon Alfa-2b Plus Ribavirin
Japan |
Chronic Hepatitis C
Hepato-biliary-pancreatic medicine |
Others
YES
To elucidate factors contributing sustained viral response of Peginterferon alfa-2b plus Ribavirin treatment in patients with chronic hepatitis C
Efficacy
Confirmatory
Explanatory
Phase IV
Sustained virological response 24 weeks after the end of treatment
Safety
Observational
20 | years-old | <= |
Not applicable |
Male and Female
Patients with chronic hepatitis C whose HCV-RNA is >= 5.0 logIU/mL or null responder or relapser to interferon monotherapy.
Any contraindication to peginterferon alfa-2b + ribavirin therapy
2000
1st name | Ryosuke |
Middle name | |
Last name | Tateishi |
The University of Tokyo Graduate School of Medicine
Department of Gastroenterology
1138655
7-3-1 Hongo, Bunkyo-ku, Tokyo
03-3815-5411
tateishi-tky@umin.ac.jp
1st name | Tatsuya |
Middle name | |
Last name | Minami |
The University of Tokyo Graduate School of Medicine
Department of Gastroenterology
1138655
7-3-1 Hongo, Bunkyo-ku, Tokyo
03-3815-5411
tminami-tky@umin.ac.jp
Department of Gastroenterology
The University of Tokyo Hospital
Japan Agency for Medical Research and Development
Japanese Governmental office
The University of Tokyo Ethics Committee
7-3-1, Hongo, Bunkyo-ku, Tokyo
03-3815-5411
ethics@m.u-tokyo.ac.jp
NO
東京大学医学部附属病院
2010 | Year | 08 | Month | 01 | Day |
https://park.itc.u-tokyo.ac.jp/livercancer/research/
Unpublished
https://park.itc.u-tokyo.ac.jp/livercancer/research/
150
The rate of SVR was 55%.
2023 | Year | 02 | Month | 13 | Day |
Enrolled patients were those with chronic hepatitis C infection who were treated with peginterferon plus ribavirin.
After written consent is obtained, the patient is enrolled, treated, and checked to see if viral eradication has been achieved.
Cases of hypothyroidism, interstitial pneumonia, skin rash, peripheral neuropathy, and dysgeusia led to discontinuation of treatment in one patient each.
The rate of SVR achievement
No longer recruiting
2010 | Year | 07 | Month | 26 | Day |
2010 | Year | 07 | Month | 26 | Day |
2010 | Year | 08 | Month | 01 | Day |
2021 | Year | 01 | Month | 31 | Day |
Patients background including sex, age, body height, body weight, BMI, medical comorbidity, previous treatment for chronic hepatitis C, liver biopsy, laboratory data, adverse events and virological response after treatment.Post SVR carcinogenesis observation is being conducted as a post observation.
2010 | Year | 08 | Month | 01 | Day |
2023 | Year | 02 | Month | 13 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004793
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