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Remission Induction of Primary Biliary Cholangitis-autoimmune Hepatitis Overlap Syndrome

Primary Purpose

Hepatitis, Autoimmune, Cholangitis, Liver Cirrhosis, Biliary

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Ursodeoxycholic acid combination of immunosuppressive agents

Ursodeoxycholic Acid

About this trial

This is an interventional treatment trial for Hepatitis, Autoimmune

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

West China HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ursodeoxycholic acid + immunosuppressive agents group

Ursodeoxycholic acid group

Arm Description

Ursodeoxycholic acid + immunosuppressive agents

Ursodeoxycholic acid

Outcomes

Primary Outcome Measures

Percent of patients that achieve biochemical remission of autoimmune hepatitis(AIH)

Secondary Outcome Measures

Alanine transaminase (ALT)

Aspartate transaminase(AST)

Immunoglobulin G(IgG)

Globin(GLB)

Total bilirubin(TB)

Direct bilirubin(DB)

Alkaline phosphatase(ALP)

Glutamyltransferase(GGT)

Side effects

Full Information

NCT ID

NCT02936596

First Posted

October 15, 2016

Last Updated

October 26, 2021

Sponsor

Xiaoli Fan

1. Study Identification

Unique Protocol Identification Number

NCT02936596

Brief Title

Remission Induction of Primary Biliary Cholangitis-autoimmune Hepatitis Overlap Syndrome

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2021

Overall Recruitment Status

Unknown status

Study Start Date

December 2016 (undefined)

Primary Completion Date

June 1, 2022 (Anticipated)

Study Completion Date

June 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Xiaoli Fan

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatitis, Autoimmune, Cholangitis, Liver Cirrhosis, Biliary, Cholestasis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

53 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Ursodeoxycholic acid + immunosuppressive agents group

Arm Type

Experimental

Arm Description

Ursodeoxycholic acid + immunosuppressive agents

Arm Title

Ursodeoxycholic acid group

Arm Type

Active Comparator

Arm Description

Ursodeoxycholic acid

Intervention Type

Drug

Intervention Name(s)

Ursodeoxycholic acid combination of immunosuppressive agents

Intervention Description

Ursodeoxycholic acid combination of immunosuppressive agents(methylprednisolone with or without azathioprine)

Intervention Type

Drug

Intervention Name(s)

Ursodeoxycholic Acid

Intervention Description

Ursodeoxycholic Acid

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

Alanine transaminase (ALT)

Time Frame

Week 2 and Month 1, 3, 6

Title

Aspartate transaminase(AST)

Time Frame

Week 2 and Month 1, 3, 6

Title

Immunoglobulin G(IgG)

Time Frame

Week 2 and Month 1, 3, 6

Title

Globin(GLB)

Time Frame

Week 2 and Month 1, 3, 6

Title

Total bilirubin(TB)

Time Frame

Week 2 and Month 1, 3, 6

Title

Direct bilirubin(DB)

Time Frame

Week 2 and Month 1, 3, 6

Title

Alkaline phosphatase(ALP)

Time Frame

Week 2 and Month 1, 3, 6

Title

Glutamyltransferase(GGT)

Time Frame

Week 2 and Month 1, 3, 6

Title

Side effects

Time Frame

Evaluation of side effects during the study period(6 months)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Xiaoli Fan, MM

Phone

+862885422311

13980433451@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Li Yang, MD

Organizational Affiliation

West China Hospital,Chengdu, Sichuan, China

Official's Role

Study Chair

Facility Information:

Facility Name

West China 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

Xiaoli Fan, MM

Phone

+8618008028017

13980433451@163.com

First Name & Middle Initial & Last Name & Degree

Li Yang, MD

yangli_hx@scu.edu.cn

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Remission Induction of Primary Biliary Cholangitis-autoimmune Hepatitis Overlap Syndrome

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