Examination of the mizoribine and azathioprine combination immunosuppressive therapy in primary sclerosing cholangitis

• Register: JPRN
• Last refreshed on: 17 October 2023
• 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: Complete
• 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

Contacts

• Name: Hitoshi Tajiri
• Affiliation: KINDAI UNIVERSITY

• Name: Hitoshi Tajiri
• Affiliation: KINDAI UNIVERSITY

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 old
Age maximum: <= 18age old
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.

Ethics review

Status: Approval
Approval date:
Contact:

[e-mail]

Medical Center Clinical Research Review Board

[phone]

[e-mail]

Results

• Results available: Yes
• Date Posted: 07/06/2021
• Date Completed: 31/03/2020