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

JRCT ID: jRCTs051180120

Registered date:13/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Primary sclerosing cholangitis; PSC
• Date of first enrollment: 01/04/2012
• Target sample size: 10
• Study type: Interventional

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.

Outcome(s)

• Primary Outcome: Liver function tests including AST, ALT, gamma-GTP, and bilirubin.

Secondary Outcome

Improvement in liver histology
Improvement in MRCP findings
Physical condition
Adverse effects, abnormal laboratory tests.

Key inclusion & exclusion criteria

• Age minimum: >= 3age old
• Age maximum: <= 18age old
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Tajiri Hitoshi