Back to resultsMycophenolate Mofetil Versus Cyclosporin A in the Treatment of Primary Biliary Cholangitis-autoimmune Hepatitis Overlap Syndrome Due to Nonresponse to Standard Therapy
Primary Purpose
Hepatitis, Autoimmune, Primary Biliary Cholangitis, Immunosuppression
Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Cyclosporin A
Mycophenolate Mofetil
Sponsored by
About this trial
This is an interventional treatment trial for Hepatitis, Autoimmune
Eligibility Criteria
Inclusion Criteria:
- 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;
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'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 ;
Sites / Locations
- WestChina HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Cyclosporin A
Mycophenolate Mofetil
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Partial remission
Partial remission, defined as alanine aminotransferase (ALT) or aspartate aminotransferase (AST) serum levels >1x Upper Limit of Normal (ULN) and <2x ULN
Minimal response
Minimal response, defined as decrease of ALT or AST serum levels but still >2x ULN
Treatment failure
defined as no improvement or increase of ALT or AST serum levels
Changes in liver stiffness
liver stiffness will be measured by shear-wave elastography
Side-effects
Drug related side-effects
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04376528
Brief Title
Mycophenolate Mofetil Versus Cyclosporin A in the Treatment of Primary Biliary Cholangitis-autoimmune Hepatitis Overlap Syndrome Due to Nonresponse to Standard Therapy
Official Title
Mycophenolate Mofetil Versus Cyclosporin A in the Treatment of Primary Biliary Cholangitis-autoimmune Hepatitis Overlap Syndrome Duo to Nonresponse to Standard Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Unknown status
Study Start Date
June 16, 2021 (Actual)
Primary Completion Date
December 30, 2021 (Anticipated)
Study Completion Date
December 30, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
West China Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Biochemical response of primary biliary cholangitis-autoimmune hepatitis overlap syndrome induced by mycophenolate mofetil versus cyclosporin A
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis, Autoimmune, Primary Biliary Cholangitis, Immunosuppression
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
89 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cyclosporin A
Arm Type
Experimental
Arm Title
Mycophenolate Mofetil
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Cyclosporin A
Intervention Description
Ursodeoxycholic acid combination of immunosuppressive agents(methylprednisolone with cyclosporin A)
Intervention Type
Drug
Intervention Name(s)
Mycophenolate Mofetil
Intervention Description
Ursodeoxycholic acid combination of immunosuppressive agents(methylprednisolone with mycophenolate mofetil )
Primary Outcome Measure Information:
Title
Biochemical remission
Description
The percentage of patients in biochemical remission, defined as normalization of serum ALT and IgG levels after 24 weeks of treatment, per treatment group.
Time Frame
up to 6 months
Secondary Outcome Measure Information:
Title
Partial remission
Description
Partial remission, defined as alanine aminotransferase (ALT) or aspartate aminotransferase (AST) serum levels >1x Upper Limit of Normal (ULN) and <2x ULN
Time Frame
up to 6 months
Title
Minimal response
Description
Minimal response, defined as decrease of ALT or AST serum levels but still >2x ULN
Time Frame
up to 6 months
Title
Treatment failure
Description
defined as no improvement or increase of ALT or AST serum levels
Time Frame
up to 6 months
Title
Changes in liver stiffness
Description
liver stiffness will be measured by shear-wave elastography
Time Frame
up to 6 months
Title
Side-effects
Description
Drug related side-effects
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;
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;
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'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 ;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaoli Fan, Master degree
Phone
+86 13980433451
Email
13980433451@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Li Yang
Phone
+86 13518178110
Email
yangli_hx@scu.edu.cn
Facility Information:
Facility Name
WestChina Hospital
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Li Yang
Phone
+86 13518178110
Email
yangli_hx@scu.edu.cn
12. IPD Sharing Statement
Plan to Share IPD
No
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Mycophenolate Mofetil Versus Cyclosporin A in the Treatment of Primary Biliary Cholangitis-autoimmune Hepatitis Overlap Syndrome Due to Nonresponse to Standard Therapy
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