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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-UMIN000029482 |
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Date of registration:
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10/10/2017 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Study of combination immunosuppressive therapy in primary sclerosing cholangitis - A multicenter study for combination immunosuppressive therapy with mizoribine and azathioprine -
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Scientific title:
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Study of combination immunosuppressive therapy in primary sclerosing cholangitis - A multicenter study for combination immunosuppressive therapy with mizoribine and azathioprine - - Study of combination immunosuppressive therapy in primary sclerosing cholangitis |
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Date of first enrolment:
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2012/04/01 |
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Target sample size:
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10 |
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Recruitment status: |
Complete: follow-up continuing |
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URL:
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https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033685 |
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Study type:
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Interventional |
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Study design:
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Single arm Non-randomized
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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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Hitoshi
Tajiri |
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Address:
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3-1-56 Bandai-Higashi, Sumiyoshi-ku, Osaka
558-8558
Japan |
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Telephone:
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06-6692-1201 |
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Email:
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tajiriji@gh.opho.jp |
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Affiliation:
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Osaka General Medical Center Department of Pediatrics |
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Name:
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Hitoshi
Tajiri |
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Address:
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3-1-56 Bandai-Higashi, Sumiyoshi-ku, Osaka
Japan |
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Telephone:
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06-6692-1201 |
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Email:
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tajiriji@gh.opho.jp |
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Affiliation:
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Osaka General Medical Center Department of Pediatrics |
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Key inclusion & exclusion criteria
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Inclusion criteria:
Exclusion criteria: 1. Patients with some history of hypersensitivity to Bredini, Imuran, or Azanin Tablets 2. WBC:<=3000/mm3 3. Pregnants or patients who desire pregnancy 4. Patients with severe allergy 5. Patients who are judged inappropriate by the principal investigator
Age minimum:
Not applicable
Age maximum:
Not applicable
Gender:
Male and Female
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Health Condition(s) or Problem(s) studied
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Primary sclerosing cholangitis
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Intervention(s)
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Administration of mizoribine and azathioprine
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Primary Outcome(s)
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Liver function (AST, ALT or gamma GTP, jaundice)
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Secondary Outcome(s)
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1.Hepatic histopathological evaluation 2.MRCP 3.Physical conditions 4.Incidence of adverse event and abnormal laboratory data
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Source(s) of Monetary Support
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None
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Ethics review
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Status: YES
Approval date: 03/03/2020
Contact:
kenkyusien@gh.opho.jp
Osaka General Medical Center
0666921201
kenkyusien@gh.opho.jp
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Results
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Results available:
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Yes |
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Date Posted:
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Date Completed:
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31/03/2020 |
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URL:
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