A Randomised Clinical Trial Assessing the Efficacy and Safety of Mycophenolate Mofetil Versus Azathioprine for Induction of Remission in Treatment Primary Biliary Cholangitis-Autoimmune Hepatitis Overlap Syndrome

NCT04933292 | Unknown Phase 4

• 1 other identifier: OS-2
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

Current standard therapy of primary biliary cholangitis-autoimmune hepatitis overlap syndrome(PBC-AIH overlap) consists of a combination of prednisolone and azathioprine. However, a significant proportion of patients may do not respond to, or is intolerant for azathioprine. Several studies have documented the efficacy and safety of mycophenolate mofetil(MMF) as second-line therapy for PBC-AIH overlap. However, robust evidence from a formal randomized clinical trial for the first-line immunosuppressor is in need.

Conditions

Autoimmune Hepatitis; Primary Biliary Cirrhosis

Outcome Measures

Primary Outcomes (1)

• Biochemical remission

  The percentage of patients in remission, defined as normalization of serum transaminase and IgG levels after 6 months of treatment, per treatment group

  6 months

Secondary Outcomes (4)

• The level of IgG value in both groups

  at 1 month

• The level of IgG value in both groups

  at 3-month

• The level of IgG value in both groups

  at 6-month

• Adverse drug reactions

  up to 6 months

Study Arms (2)

Methylprednisolone and Mycophenolate mofetil

EXPERIMENTAL

Drug: Methylprednisolone and Mycophenolate mofetil

Methylprednisolone and Azathioprine

ACTIVE COMPARATOR

Drug: Methylprednisolone and azathioprine

Interventions

Methylprednisolone and Mycophenolate mofetil DRUG

Methylprednisolone combination of mycophenolate mofetil

Methylprednisolone and Mycophenolate mofetil

Methylprednisolone and azathioprine DRUG

Methylprednisolone combination of azathioprine

Methylprednisolone and Azathioprine

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;
• Agreed to participate in the trial, and assigned informed consent;
• The WBC count ≥2.5x10\^9/L and platelet count ≥50x10\^9/L.

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 disease.
• Pregnant and breeding women;
• Severe disorders of other vital organs, such as severe heart failure, cancer;
• 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.

Sponsors & Collaborators

• Xiaoli Fan: lead

Study Sites (1)

West China Hospital of Sichuan Univerisity

Chengdu, Sichuan, 610041, China

RECRUITING

MeSH Terms

Conditions

Hepatitis, Autoimmune; Liver Cirrhosis, Biliary

Interventions

Methylprednisolone; Mycophenolic Acid; Azathioprine

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)

Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Caproates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids; Lipids; Thionucleosides; Sulfur Compounds; Mercaptopurine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Central Study Contacts

Xiaoli Fan, Master degree

CONTACT

+86 13980433451; 13980433451@163.com

Study Design

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

Study Record Dates

• First Submitted: May 1, 2020
• First Posted: June 21, 2021
• Study Start: June 16, 2021
• Primary Completion: May 1, 2022
• Study Completion: May 1, 2022
• Last Updated: June 21, 2021

Record last verified: 2021-06

Locations

CN (1)