Remission Induction of Primary Biliary Cholangitis-autoimmune Hepatitis Overlap Syndrome

October 26, 2021 updated by: Xiaoli Fan

Biochemical Response of Primary Biliary Cholangitis-autoimmune Hepatitis Overlap Syndrome Induced by Ursodeoxycholic Acid Only or Combination Therapy of Immunosuppressive Agents

Biochemical response of primary biliary cholangitis-autoimmune hepatitis overlap syndrome induced by ursodeoxycholic acid only or combination therapy of immunosuppressive agents

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

53

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 1.Patients aged 18-70 years;
  • 2.Diagnosed with primary biliary cholangitis-autoimmune hepatitis overlap syndrome according to Paris criteria, based on liver biopsy results obtained 3 months before screening;
  • 3.White blood cell count ≥2.5x10^9/L or platelet count ≥50x10^9/L at inclusion;
  • 4.Agreed to participate in the trial, and assigned informed consent.

Exclusion Criteria:

  • 1. The presence of hepatitis A, B, C, D, or E virus infection;
  • 2. Patients with indications for immunosuppressive treatment at inclusion: serum alanine transaminase(ALT) or aspartate transaminase(AST) ≥10 fold upper limit of normal(ULN)，or serum ALT or AST≥ 5 fold ULN and γglobulin level ≥ 2 fold ULN, or bridging necrosis or multiacinar necrosis on histological examination.
  • 3. Patients with complications of cirrhosis;
  • 4. Patients with previous treatment of immunosuppressive agents or traditional Chinese medicine for more than one month;
  • 5. Primary sclerosing cholangitis,non-alcoholic steatohepatitis,drug induced liver disease or Wilson's disease confirmed by liver biopsy;
  • 6. Pregnant and breeding women;
  • 7. Severe disorders of other vital organs, such as severe heart failure, cancer;
  • 8. Parenteral administration of blood or blood products within 6 months before screening;
  • 9. Recent treatment with drugs having known liver toxicity;
  • 10.Taken part in other clinic trials within 6 months before screening.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ursodeoxycholic acid + immunosuppressive agents group
Ursodeoxycholic acid + immunosuppressive agents
Drug: Ursodeoxycholic acid combination of immunosuppressive agents
Ursodeoxycholic acid combination of immunosuppressive agents(methylprednisolone with or without azathioprine)
Active Comparator: Ursodeoxycholic acid group
Ursodeoxycholic acid
Drug: Ursodeoxycholic Acid
Ursodeoxycholic Acid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percent of patients that achieve biochemical remission of autoimmune hepatitis(AIH)
Time Frame: Month 6 during treatment with ursodeoxycholic acid only or combination therapy of immunosuppressive agents
Month 6 during treatment with ursodeoxycholic acid only or combination therapy of immunosuppressive agents

Secondary Outcome Measures

Outcome Measure
Time Frame
Alanine transaminase (ALT)
Time Frame: Week 2 and Month 1, 3, 6
Week 2 and Month 1, 3, 6
Aspartate transaminase(AST)
Time Frame: Week 2 and Month 1, 3, 6
Week 2 and Month 1, 3, 6
Immunoglobulin G(IgG)
Time Frame: Week 2 and Month 1, 3, 6
Week 2 and Month 1, 3, 6
Globin(GLB)
Time Frame: Week 2 and Month 1, 3, 6
Week 2 and Month 1, 3, 6
Total bilirubin(TB)
Time Frame: Week 2 and Month 1, 3, 6
Week 2 and Month 1, 3, 6
Direct bilirubin(DB)
Time Frame: Week 2 and Month 1, 3, 6
Week 2 and Month 1, 3, 6
Alkaline phosphatase(ALP)
Time Frame: Week 2 and Month 1, 3, 6
Week 2 and Month 1, 3, 6
Glutamyltransferase(GGT)
Time Frame: Week 2 and Month 1, 3, 6
Week 2 and Month 1, 3, 6
Side effects
Time Frame: Evaluation of side effects during the study period(6 months)
Evaluation of side effects during the study period(6 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xiaoli Fan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2016

Primary Completion (Anticipated)

June 1, 2022

Study Completion (Anticipated)

June 1, 2022

Study Registration Dates

First Submitted

October 15, 2016

First Submitted That Met QC Criteria

October 15, 2016

First Posted (Estimate)

October 18, 2016

Study Record Updates

Last Update Posted (Actual)

October 27, 2021

Last Update Submitted That Met QC Criteria

October 26, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OS-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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