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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: 25 February 2020
Main ID:  JPRN-jRCTs051180120
Date of registration: 13/03/2019
Prospective Registration: No
Primary sponsor: Tajiri Hitoshi
Public title: Examination of the mizoribine and azathioprine combination immunosuppressive therapy in primary sclerosing cholangitis
Scientific title: Examination of the immunosuppressive drug combination therapy in primary sclerosing cholangitis Study of the mizoribine and azathioprine combination immunosuppressive therapy - Examination of the immunosuppressive drug combination therapy in primary sclerosing cholangitis
Date of first enrolment: 01/04/2012
Target sample size: 10
Recruitment status: Recruiting
URL:  https://jrct.niph.go.jp/latest-detail/jRCTs051180120
Study type:  Interventional
Study design:  single arm study, open(masking not used), uncontrolled control, single assignment, treatment purpose  
Phase:  2
Countries of recruitment
Japan
Contacts
Name: Hitoshi    Tajiri
Address:  3-1-56 Bandai-Higashi Sumiyosi-ku Osaka,Japan 558-8558 Osaka Japan
Telephone: +81-6-6692-1201
Email: tajiriji@gh.opho.jp
Affiliation:  Osaka General Medical Center
Name: Hitoshi    Tajiri
Address:  3-1-56 Bandai-higasi Sumiyosi-ku Osaka,Japan 558-8558 Osaka Japan
Telephone: +81-6-6692-1201
Email: tajiriji@gh.opho.jp
Affiliation:  Osaka General Medical Center
Key inclusion & exclusion criteria
Inclusion criteria: 1.Primary sclerosing cholangitis
2. No condition on primary disease.
3.Patients age is 18 years old from 3 years old at the agreement acquisition.
3.No condition on primary disease.
4.When there are complications such as an esophagus varix, the cirrhosis, it depends on a chief physician judgment
5.Written informed consent after adequate explanation and acceptance.

Exclusion criteria: 1.History of hypersensitivity to any ingredients of Bredinin, Imuran, or Azanin.
2.Patients with WBC less than 3000/m3.
3.Patients with severe degree of allergic diseases.
4.Patients who are assessed to be ineligible for this study by the principle investigator.


Age minimum: 3age
Age maximum: 18age
Gender: Both
Health Condition(s) or Problem(s) studied
K830
Primary sclerosing cholangitis; PSC
Intervention(s)
1 MZR
Daily intake of mizoribine once before breakfast. Dose adjustment is done to achieve a blood concentration level over 3.0 microg/ml at 3 hour after meal.
2)AZT
Daily intake of azathioprine once after breakfast and once after dinner.
Starting dose is 0.5-1.0mg/kg daily (max 2.0mg) , is increased according to the condition of patients. Dose is adjusted to achieve WBC 3000-5000/m3, neutrophils 2000-3500/m3(the dose of 6MP is appotoimatery half of azathioprine). Continue the dosage during a study period.
Primary Outcome(s)
Liver function tests including AST, ALT, gamma-GTP, and bilirubin.
Secondary Outcome(s)
Improvement in liver histology
Improvement in MRCP findings
Physical condition
Adverse effects, abnormal laboratory tests.
Secondary ID(s)
Source(s) of Monetary Support
Secondary Sponsor(s)
Ethics review
Status: Approval
Approval date: 06/02/2019
Contact:
kenkyusien@gh.opho.jp
Osaka General Medical Center Clinical Research Review Board
+81-6-6692-1201
kenkyusien@gh.opho.jp
Results
Results available:
Date Posted:
Date Completed:
URL:
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