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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