Remission Induction of Primary Biliary Cholangitis-autoimmune Hepatitis Overlap Syndrome
Overview
Biochemical response of primary biliary cholangitis-autoimmune hepatitis overlap syndrome induced by ursodeoxycholic acid only or combination therapy of immunosuppressive agents
Full Title of Study: “Biochemical Response of Primary Biliary Cholangitis-autoimmune Hepatitis Overlap Syndrome Induced by Ursodeoxycholic Acid Only or Combination Therapy of Immunosuppressive Agents”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: None (Open Label)
- Study Primary Completion Date: June 1, 2022
Interventions
- Drug: Ursodeoxycholic acid combination of immunosuppressive agents
- Ursodeoxycholic acid combination of immunosuppressive agents(methylprednisolone with or without azathioprine)
- Drug: Ursodeoxycholic Acid
- Ursodeoxycholic Acid
Arms, Groups and Cohorts
- Experimental: Ursodeoxycholic acid + immunosuppressive agents group
- Ursodeoxycholic acid + immunosuppressive agents
- Active Comparator: Ursodeoxycholic acid group
- Ursodeoxycholic acid
Clinical Trial Outcome Measures
Primary Measures
- 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 Measures
- Alanine transaminase (ALT)
- Time Frame: Week 2 and Month 1, 3, 6
- Aspartate transaminase(AST)
- Time Frame: Week 2 and Month 1, 3, 6
- Immunoglobulin G(IgG)
- Time Frame: Week 2 and Month 1, 3, 6
- Globin(GLB)
- Time Frame: Week 2 and Month 1, 3, 6
- Total bilirubin(TB)
- Time Frame: Week 2 and Month 1, 3, 6
- Direct bilirubin(DB)
- Time Frame: Week 2 and Month 1, 3, 6
- Alkaline phosphatase(ALP)
- Time Frame: Week 2 and Month 1, 3, 6
- Glutamyltransferase(GGT)
- Time Frame: Week 2 and Month 1, 3, 6
- Side effects
- Time Frame: Evaluation of side effects during the study period(6 months)
Participating in This Clinical Trial
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 ≥2.5×10^9/L or platelet count ≥50×10^9/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.
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: 75 Years
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- Xiaoli Fan
- Provider of Information About this Clinical Study
- Sponsor-Investigator: Xiaoli Fan, Master Degree – West China Hospital
- Overall Official(s)
- Li Yang, MD, Study Chair, West China Hospital,Chengdu, Sichuan, China
- Overall Contact(s)
- Xiaoli Fan, MM, +862885422311, 13980433451@163.com
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