Back to resultsA 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 Purpose
Autoimmune Hepatitis, Primary Biliary Cirrhosis
Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Methylprednisolone and Mycophenolate mofetil
Methylprednisolone and azathioprine
Sponsored by
About this trial
This is an interventional treatment trial for Autoimmune Hepatitis
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- West China Hospital of Sichuan UniverisityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Methylprednisolone and Mycophenolate mofetil
Methylprednisolone and Azathioprine
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
The level of IgG value in both groups
The level of IgG value in both groups
The level of IgG value in both groups
Adverse drug reactions
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04933292
Brief 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
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Unknown status
Study Start Date
June 16, 2021 (Actual)
Primary Completion Date
May 2022 (Anticipated)
Study Completion Date
May 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Xiaoli Fan
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autoimmune Hepatitis, Primary Biliary Cirrhosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
78 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Methylprednisolone and Mycophenolate mofetil
Arm Type
Experimental
Arm Title
Methylprednisolone and Azathioprine
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Methylprednisolone and Mycophenolate mofetil
Intervention Description
Methylprednisolone combination of mycophenolate mofetil
Intervention Type
Drug
Intervention Name(s)
Methylprednisolone and azathioprine
Intervention Description
Methylprednisolone combination of azathioprine
Primary Outcome Measure Information:
Title
Biochemical remission
Description
The percentage of patients in remission, defined as normalization of serum transaminase and IgG levels after 6 months of treatment, per treatment group
Time Frame
6 months
Secondary Outcome Measure Information:
Title
The level of IgG value in both groups
Time Frame
at 1 month
Title
The level of IgG value in both groups
Time Frame
at 3-month
Title
The level of IgG value in both groups
Time Frame
at 6-month
Title
Adverse drug reactions
Time Frame
up to 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaoli Fan, Master degree
Phone
+86 13980433451
Email
13980433451@163.com
Facility Information:
Facility Name
West China Hospital of Sichuan Univerisity
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaoli Fan, PhD
12. IPD Sharing Statement
Learn more about this trial
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
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