Status:
UNKNOWN
Mycophenolate Mofetil Versus Cyclosporin A in the Treatment of Primary Biliary Cholangitis-autoimmune Hepatitis Overlap Syndrome Due to Nonresponse to Standard Therapy
Lead Sponsor:
West China Hospital
Conditions:
Hepatitis, Autoimmune
Primary Biliary Cholangitis
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
Brief Summary
Biochemical response of primary biliary cholangitis-autoimmune hepatitis overlap syndrome induced by mycophenolate mofetil versus cyclosporin A
Eligibility Criteria
Inclusion
- Patients aged 18-70 years;
- Diagnosed with PBC-AIH overlap syndrome according to Paris criteria;
- Patients have a nonresponse to azathioprine;
- The WBC count ≥2.5x10\^9/L and platelet count ≥50x10\^9/L.
- Agreed to participate in the trial, and assigned informed consent;
Exclusion
- The presence of hepatitis A, B, C, D, or E virus infection;
- Patients with presence of serious decompensated cirrhosis;
- Patients have a history of glucocorticoid or immunosuppressant medication before enrollment;
- Liver damage caused by other reasons: such as primary sclerosing cholangitis, non-alcoholic steatohepatitis, drug induced liver disease or Wilson's disease.
- Pregnant and breeding women and women of childbearing age in need of reproduction
- Severe disorders of other vital organs, such as severe heart failure, cancer;
- Patients with presence of renal insufficiency;
- Parenteral administration of blood or blood products within 6 months before screening;
- Recent treatment with drugs having known liver toxicity;
- Taken part in other clinic trials within 6 months before enrollment.
- Patients who are allergic to these drugs;
- Uncontrolled infection and hypertension ;
Key Trial Info
Start Date :
June 16 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2021
Estimated Enrollment :
89 Patients enrolled
Trial Details
Trial ID
NCT04376528
Start Date
June 16 2021
End Date
December 30 2021
Last Update
June 22 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
WestChina Hospital
Chengdu, Sichuan, China, 610041