Remission Induction of Primary Biliary Cholangitis-autoimmune Hepatitis Overlap Syndrome

Not Applicable

• Conditions: Hepatitis, Autoimmune; Cholangitis; Liver Cirrhosis, Biliary; Cholestasis
• Interventions: Drug: Ursodeoxycholic acid combination of immunosuppressive agents; Drug: Ursodeoxycholic Acid

• Registration Number: NCT02936596
• Lead Sponsor: Xiaoli Fan

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-10-15
• Study First Submitted QC: 2016-10-15
• Study First Posted: 2016-10-18
• Study Start: 2016-12
• Status Verified: 2021-05
• Last Update Submitted: 2021-10-26
• Last Update Posted: 2021-10-27
• Primary Completion: 2022-06-01
• Study Completion: 2022-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 53

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ursodeoxycholic acid + immunosuppressive agents group	Ursodeoxycholic acid combination of immunosuppressive agents	Ursodeoxycholic acid + immunosuppressive agents
Ursodeoxycholic acid group	Ursodeoxycholic Acid	Ursodeoxycholic acid

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

West China Hospital; 🇨🇳 Chengdu, Sichuan, China