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

Phase 4

• Conditions: Primary Biliary Cirrhosis; Autoimmune Hepatitis
• Interventions: Drug: Methylprednisolone and Mycophenolate mofetil; Drug: Methylprednisolone and azathioprine

• Registration Number: NCT04933292
• Lead Sponsor: Xiaoli Fan

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-05-01
• Status Verified: 2021-06
• Study Start: 2021-06-16
• Study First Submitted QC: 2021-06-18
• Last Update Submitted: 2021-06-18
• Study First Posted: 2021-06-21
• Last Update Posted: 2021-06-21
• Primary Completion: 2022-05
• Study Completion: 2022-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 78

Inclusion Criteria

1. Patients aged 18-70 years;
2. Diagnosed with PBC-AIH overlap syndrome according to Paris criteria;
3. Agreed to participate in the trial, and assigned informed consent;
4. The WBC count ≥2.5x10^9/L and platelet count ≥50x10^9/L.

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 disease.
5. Pregnant and breeding women;
6. Severe disorders of other vital organs, such as severe heart failure, cancer;
7. Parenteral administration of blood or blood products within 6 months before screening;
8. Recent treatment with drugs having known liver toxicity;
9. Taken part in other clinic trials within 6 months before enrollment.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Methylprednisolone and Mycophenolate mofetil	Methylprednisolone and Mycophenolate mofetil	-
Methylprednisolone and Azathioprine	Methylprednisolone and azathioprine	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Adverse drug reactions	up to 6 months
The level of IgG value in both groups	at 6-month

Trial Locations

Locations (1)

West China Hospital of Sichuan Univerisity; 🇨🇳 Chengdu, Sichuan, China