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

NCT04376528 | Unknown Phase 4

• 1 other identifier: OS-3
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hepatitis, Autoimmune; Primary Biliary Cholangitis; Immunosuppression

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Partial remission

  up to 6 months

• Minimal response

  up to 6 months

• Treatment failure

  up to 6 months

• Changes in liver stiffness

  up to 6 months

• Side-effects

  up to 6 months

Study Arms (2)

Cyclosporin A

EXPERIMENTAL

Drug: Cyclosporin A

Mycophenolate Mofetil

ACTIVE COMPARATOR

Drug: Mycophenolate Mofetil

Interventions

Cyclosporin A DRUG

Ursodeoxycholic acid combination of immunosuppressive agents(methylprednisolone with cyclosporin A)

Cyclosporin A

Mycophenolate Mofetil DRUG

Ursodeoxycholic acid combination of immunosuppressive agents(methylprednisolone with mycophenolate mofetil )

Mycophenolate Mofetil

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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 ;

Sponsors & Collaborators

• West China Hospital: lead

Study Sites (1)

WestChina Hospital

Chengdu, Sichuan, 610041, China

RECRUITING

MeSH Terms

Conditions

Hepatitis, Autoimmune; Liver Cirrhosis, Biliary

Interventions

Cyclosporine; Mycophenolic Acid

Condition Hierarchy (Ancestors)

Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Autoimmune Diseases; Immune System Diseases; Cholestasis, Intrahepatic; Cholestasis; Bile Duct Diseases; Biliary Tract Diseases; Liver Cirrhosis; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclosporins; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins; Caproates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids; Lipids

Central Study Contacts

Xiaoli Fan, Master degree

CONTACT

+86 13980433451; 13980433451@163.com

Li Yang

CONTACT

+86 13518178110; yangli_hx@scu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 3, 2020
• First Posted: May 6, 2020
• Study Start: June 16, 2021
• Primary Completion: December 30, 2021
• Study Completion: December 30, 2021
• Last Updated: June 22, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)