Mycophenolate Mofetil Versus Cyclosporin A in the Treatment of Primary Biliary Cholangitis-autoimmune Hepatitis Overlap Syndrome Due to Nonresponse to Standard Therapy

Immunosuppression Clinical Trial

Official title:

Mycophenolate Mofetil Versus Cyclosporin A in the Treatment of Primary Biliary Cholangitis-autoimmune Hepatitis Overlap Syndrome Duo to Nonresponse to Standard Therapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04376528
• Other study ID #: OS-3
• Status: Recruiting
• Phase: Phase 4
• Start date: June 16, 2021
• Est. completion date: December 30, 2021

Study information

• Verified date: May 2021
• Source: West China Hospital
• Contact: Xiaoli Fan, Master degree
• Phone: +86 13980433451
• Email: 13980433451[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Biochemical response of primary biliary cholangitis-autoimmune hepatitis overlap syndrome induced by mycophenolate mofetil versus cyclosporin A

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 89
• Est. completion date: December 30, 2021
• Est. primary completion date: December 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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 enrollment;

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 ;

Related Conditions & MeSH terms

• Cholangitis
• Hepatitis
• Hepatitis A
• Hepatitis, Autoimmune
• Immunosuppression
• Liver Cirrhosis, Biliary
• Primary Biliary Cholangitis
• Undifferentiated Connective Tissue Diseases

Intervention

Drug:
• Cyclosporin A
Ursodeoxycholic acid combination of immunosuppressive agents(methylprednisolone with cyclosporin A)
• Mycophenolate Mofetil
Ursodeoxycholic acid combination of immunosuppressive agents(methylprednisolone with mycophenolate mofetil )

Locations

Country	Name	City	State
China	WestChina Hospital	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
West China Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Biochemical remission	The percentage of patients in biochemical remission, defined as normalization of serum ALT and IgG levels after 24 weeks of treatment, per treatment group.	up to 6 months
Secondary	Partial remission	Partial remission, defined as alanine aminotransferase (ALT) or aspartate aminotransferase (AST) serum levels >1x Upper Limit of Normal (ULN) and <2x ULN	up to 6 months
Secondary	Minimal response	Minimal response, defined as decrease of ALT or AST serum levels but still >2x ULN	up to 6 months
Secondary	Treatment failure	defined as no improvement or increase of ALT or AST serum levels	up to 6 months
Secondary	Changes in liver stiffness	liver stiffness will be measured by shear-wave elastography	up to 6 months
Secondary	Side-effects	Drug related side-effects	up to 6 months