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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.
Register: JPRN
Last refreshed on: 4 November 2020
Main ID:  JPRN-UMIN000029482
Date of registration: 10/10/2017
Prospective Registration: No
Primary sponsor: Osaka General Medical Center
Public title: Study of combination immunosuppressive therapy in primary sclerosing cholangitis - A multicenter study for combination immunosuppressive therapy with mizoribine and azathioprine -
Scientific title: 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
Date of first enrolment: 2012/04/01
Target sample size: 10
Recruitment status: Complete: follow-up continuing
URL:  https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033685
Study type:  Interventional
Study design:  Single arm Non-randomized  
Phase:  Not selected
Countries of recruitment
Japan
Contacts
Name: Hitoshi    Tajiri
Address:  3-1-56 Bandai-Higashi, Sumiyoshi-ku, Osaka 558-8558 Japan
Telephone: 06-6692-1201
Email: tajiriji@gh.opho.jp
Affiliation:  Osaka General Medical Center Department of Pediatrics
Name: Hitoshi    Tajiri
Address:  3-1-56 Bandai-Higashi, Sumiyoshi-ku, Osaka Japan
Telephone: 06-6692-1201
Email: tajiriji@gh.opho.jp
Affiliation:  Osaka General Medical Center Department of Pediatrics
Key inclusion & exclusion criteria
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
Health Condition(s) or Problem(s) studied
Primary sclerosing cholangitis
Intervention(s)
Administration of mizoribine and azathioprine
Primary Outcome(s)
Liver function (AST, ALT or gamma GTP, jaundice)
Secondary Outcome(s)
1.Hepatic histopathological evaluation
2.MRCP
3.Physical conditions
4.Incidence of adverse event and abnormal laboratory data
Secondary ID(s)
Source(s) of Monetary Support
None
Secondary Sponsor(s)
Ethics review
Status: YES
Approval date: 03/03/2020
Contact:
kenkyusien@gh.opho.jp
Osaka General Medical Center
0666921201
kenkyusien@gh.opho.jp
Results
Results available:
Date Posted:
Date Completed: 31/03/2020
URL:
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