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

Primary Biliary Cirrhosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04933292
• Other study ID #: OS-2
• Status: Recruiting
• Phase: Phase 4
• Start date: June 16, 2021
• Est. completion date: May 2022

Study information

• Verified date: June 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 78
• Est. completion date: May 2022
• Est. primary completion date: May 2022
• 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. 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.

Related Conditions & MeSH terms

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

Intervention

Drug:
• Methylprednisolone and Mycophenolate mofetil
Methylprednisolone combination of mycophenolate mofetil
• Methylprednisolone and azathioprine
Methylprednisolone combination of azathioprine

Locations

Country	Name	City	State
China	West China Hospital of Sichuan Univerisity	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
Xiaoli Fan

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The level of IgG value in both groups		at 1 month
Secondary	The level of IgG value in both groups		at 3-month
Secondary	The level of IgG value in both groups		at 6-month
Secondary	Adverse drug reactions		up to 6 months