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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.
Last refreshed on: 12 December 2020
Main ID:  NCT04376528
Date of registration: 03/05/2020
Prospective Registration: Yes
Primary sponsor: West China Hospital
Public title: Mycophenolate Mofetil Versus Cyclosporin A in the Treatment of Primary Biliary Cholangitis-autoimmune Hepatitis Overlap Syndrome Due to Nonresponse to Standard Therapy
Scientific title: Mycophenolate Mofetil Versus Cyclosporin A in the Treatment of Primary Biliary Cholangitis-autoimmune Hepatitis Overlap Syndrome Duo to Nonresponse to Standard Therapy
Date of first enrolment: May 30, 2020
Target sample size: 89
Recruitment status: Not yet recruiting
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).  
Phase:  Phase 4
Countries of recruitment
Name:     Li Yang, Master degree
Telephone: +86 13518178110
Key inclusion & exclusion criteria

Inclusion Criteria:

1. Patients aged 18-70 years;

2. Diagnosed with PBC-AIH overlap syndrome according to Paris criteria;

3. Patients have a nonresponse to azathioprine;

4. The WBC count =2.5x10^9/L and platelet count =50x10^9/L.

5. Agreed to participate in the trial, and assigned informed consent;

Exclusion Criteria:

1. The presence of hepatitis A, B, C, D, or E virus infection;

2. Patients with presence of serious decompensated cirrhosis;

3. Patients have a history of glucocorticoid or immunosuppressant medication before

4. Liver damage caused by other reasons: such as primary sclerosing cholangitis,
non-alcoholic steatohepatitis, drug induced liver disease or Wilson's disease.

5. Pregnant and breeding women and women of childbearing age in need of reproduction

6. Severe disorders of other vital organs, such as severe heart failure, cancer;

7. Patients with presence of renal insufficiency;

8. Parenteral administration of blood or blood products within 6 months before screening;

9. Recent treatment with drugs having known liver toxicity;

10. Taken part in other clinic trials within 6 months before enrollment.

11. Patients who are allergic to these drugs;

12. Uncontrolled infection and hypertension ;

Age minimum: 18 Years
Age maximum: 70 Years
Gender: All
Health Condition(s) or Problem(s) studied
Hepatitis, Autoimmune
Primary Biliary Cholangitis
Drug: Cyclosporin A
Drug: Mycophenolate Mofetil
Primary Outcome(s)
Biochemical remission [Time Frame: up to 6 months]
Secondary Outcome(s)
Changes in liver stiffness [Time Frame: up to 6 months]
Minimal response [Time Frame: up to 6 months]
Partial remission [Time Frame: up to 6 months]
Side-effects [Time Frame: up to 6 months]
Treatment failure [Time Frame: up to 6 months]
Secondary ID(s)
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results available:
Date Posted:
Date Completed:
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