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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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JPRN |
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Last refreshed on:
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17 October 2023 |
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Main ID: |
JPRN-UMIN000018371 |
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Date of registration:
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01/08/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Efficacy of Pegylated interferon treatment for chronic hepatitis B
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Scientific title:
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Efficacy of Pegylated interferon treatment for chronic hepatitis B - Efficacy of Pegylated interferon |
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Date of first enrolment:
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2015/08/01 |
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Target sample size:
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100 |
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Recruitment status: |
Recruiting |
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URL:
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https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021253 |
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Study type:
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Observational |
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Study design:
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Not selected Not selected
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Phase:
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Not selected
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Countries of recruitment
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Japan
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Contacts
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Name:
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Ryoko
Yamada |
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Address:
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2-2, Yamadaoka, Suita, Osaka, Japan
565-0871
Japan |
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Telephone:
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81-6-6879-3621 |
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Email:
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ryo726@gh.med.osaka-u.ac.jp |
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Affiliation:
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Osaka University Graduate School of Medicine Gastroenterology and Hepatology |
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Name:
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Tetsuo
Takehara |
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Address:
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2-2, Yamadaoka, Suita, Osaka, Japan
Japan |
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Telephone:
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81-6-6879-3621 |
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Email:
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takehara@gh.med.osaka-u.ac.jp |
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Affiliation:
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Osaka University Graduate School of Medicine Gastroenterology and Hepatology |
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Key inclusion & exclusion criteria
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Inclusion criteria:
Exclusion criteria: 1)pregnant woman 2)co-infection with other hepatitis virus (HCV/HDV/HIV) 3)other liver disease such as autoimmune hepatitis, alcoholic liver disease etc. 4)comorbidity with other severe disease or immune dificiency 5)severe depression or other severe mental disease 6)contraindication for interferon treatment
Age minimum:
20years-old
Age maximum:
Not applicable
Gender:
Male and Female
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Health Condition(s) or Problem(s) studied
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patients with chronic hepatitis B infection
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Primary Outcome(s)
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probability of HBV DNA negativity decrease rate of HB surface antigen level decrease rate of HB core-related antigen probability of ALT normalization probability of HBe antigen seroconversion cumulative incidence rate of hepatocellular carcinoma
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Secondary Outcome(s)
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improvement of liver fibrosis
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Source(s) of Monetary Support
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Grant-in-Aid for Research on Hepatitis from Ministry of Health Labour and Welfare of Japan, and Scientific Research from the Ministry of Education, Science, and Culture of Japan
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Ethics review
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Status: YES
Approval date:
Contact:
rinri@hp-crc.med.osaka-u.ac.jp
Osaka University Clinical Research Review Committee
06-6210-8289
rinri@hp-crc.med.osaka-u.ac.jp
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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