Ursodeoxycholic Acid Combined With Low Dose Glucocorticoid in the Treatment of PBC With AIH Features II
Primary Purpose
Hepatitis, Autoimmune, Primary Biliary Cholangitis
Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Ursodeoxycholic acid
Ursodeoxycholic acid+Low Dose Glucocorticoid(Methylprednisolone)
Sponsored by
About this trial
This is an interventional treatment trial for Hepatitis, Autoimmune focused on measuring Glucocorticoid, Ursodeoxycholic Acid
Eligibility Criteria
Inclusion Criteria:
- Patients aged 18-75 years;
- The diagnosis of PBC is clear and does not meet the Paris criteria for diagnosing PBC overlap AIH, but it needs to meet 3xULN < ALT < 5xULN or 3xULN < AST < 5xULN or 1.3xULN < IgG < 2xULN, and liver pathological biopsy excludes moderate or higher interface inflammation;
- 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 cirrhosis;
- Patients with presence of fulminant liver failure;
- 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;
- 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 with contraindications of glucocorticoid
Sites / Locations
- Division of Gastroenterology & Hepatology,West China Hospital,Sichuan UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Ursodeoxycholic Acid group
Ursodeoxycholic Acid+Low Dose Glucocorticoid group
Arm Description
Ursodeoxycholic Acid 13-15mg/kg/d
Ursodeoxycholic Acid 13-15mg/kg/d+Methylprednisolone 12mg/d in induction period and 2-4mg/d in maintenance period
Outcomes
Primary Outcome Measures
Biochemical remission
The percentage of patients in biochemical remission, defined as normalization of serum ALT and IgG levels after treatment, per treatment group.
Secondary Outcome Measures
Partial remission
Partial remission, defined as ALT or 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
ALT,AST,IgG
serum ALT,AST and IgG levels
percentage of immune cells
percentage of T cells, cDC, MDSC, Treg, Breg, plasma cells, NK, NKT
Side-effects
Drug related side-effects
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04617561
Brief Title
Ursodeoxycholic Acid Combined With Low Dose Glucocorticoid in the Treatment of PBC With AIH Features II
Official Title
Ursodeoxycholic Acid Combined With Low Dose Glucocorticoid in the Treatment of PBC With AIH Features II:A Randomized Controlled Open-label Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
November 1, 2020 (Actual)
Primary Completion Date
November 1, 2022 (Anticipated)
Study Completion Date
November 1, 2022 (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
A randomized controlled open-label clinical trial of ursodeoxycholic acid combined with low dose glucocorticoid in the treatment of PBC With AIH Features II to asses efficacy and safety.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis, Autoimmune, Primary Biliary Cholangitis
Keywords
Glucocorticoid, Ursodeoxycholic Acid
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Ursodeoxycholic Acid group
Arm Type
Active Comparator
Arm Description
Ursodeoxycholic Acid 13-15mg/kg/d
Arm Title
Ursodeoxycholic Acid+Low Dose Glucocorticoid group
Arm Type
Experimental
Arm Description
Ursodeoxycholic Acid 13-15mg/kg/d+Methylprednisolone 12mg/d in induction period and 2-4mg/d in maintenance period
Intervention Type
Drug
Intervention Name(s)
Ursodeoxycholic acid
Other Intervention Name(s)
UDCA;Ursofalk(250mg*25,Losan Pharma GmbH)
Intervention Description
Participants received Ursodeoxycholic acid (13-15mg/kg/d po.)
Intervention Type
Drug
Intervention Name(s)
Ursodeoxycholic acid+Low Dose Glucocorticoid(Methylprednisolone)
Other Intervention Name(s)
Medrol(4mg*30,pfizer ltalia srl)
Intervention Description
Participants received Methylprednisolone (12mg/d po. in induction and 2-4mg/d in maintenance) combined with Ursodeoxycholic acid (13-15mg/kg/d po.)
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 treatment, per treatment group.
Time Frame
up to 12 months
Secondary Outcome Measure Information:
Title
Partial remission
Description
Partial remission, defined as ALT or AST serum levels >1x Upper Limit of Normal (ULN) and <2x ULN
Time Frame
up to 12 months
Title
Minimal response
Description
Minimal response, defined as decrease of ALT or AST serum levels but still >2x ULN
Time Frame
up to 12 months
Title
Treatment failure
Description
defined as no improvement or increase of ALT or AST serum levels
Time Frame
up to 12 months
Title
ALT,AST,IgG
Description
serum ALT,AST and IgG levels
Time Frame
baseline and month 3,6,12
Title
percentage of immune cells
Description
percentage of T cells, cDC, MDSC, Treg, Breg, plasma cells, NK, NKT
Time Frame
baseline and month 12
Title
Side-effects
Description
Drug related side-effects
Time Frame
up to 12 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 18-75 years;
The diagnosis of PBC is clear and does not meet the Paris criteria for diagnosing PBC overlap AIH, but it needs to meet 3xULN < ALT < 5xULN or 3xULN < AST < 5xULN or 1.3xULN < IgG < 2xULN, and liver pathological biopsy excludes moderate or higher interface inflammation;
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 cirrhosis;
Patients with presence of fulminant liver failure;
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;
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 with contraindications of glucocorticoid
Facility Information:
Facility Name
Division of Gastroenterology & Hepatology,West China Hospital,Sichuan University
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, MD
Phone
+86 18980601276
Email
yangli_hx@scu.edu.cn
First Name & Middle Initial & Last Name & Degree
Chen Huang
Phone
+86 18328089415
Email
huangchen0323@163.com
First Name & Middle Initial & Last Name & Degree
Chen Huang
12. IPD Sharing Statement
Plan to Share IPD
No
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Ursodeoxycholic Acid Combined With Low Dose Glucocorticoid in the Treatment of PBC With AIH Features II
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