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Remission Induction of Primary Biliary Cholangitis-autoimmune Hepatitis Overlap Syndrome

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ClinicalTrials.gov Identifier: NCT02936596
Recruitment Status : Recruiting
First Posted : October 18, 2016
Last Update Posted : May 4, 2020
Sponsor:
Information provided by (Responsible Party):
Xiaoli Fan, West China Hospital

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

Condition or disease Intervention/treatment Phase
Hepatitis, Autoimmune Cholangitis Liver Cirrhosis, Biliary Cholestasis Drug: Ursodeoxycholic acid combination of immunosuppressive agents Drug: Ursodeoxycholic Acid Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 53 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Biochemical Response of Primary Biliary Cholangitis-autoimmune Hepatitis Overlap Syndrome Induced by Ursodeoxycholic Acid Only or Combination Therapy of Immunosuppressive Agents
Study Start Date : December 2016
Estimated Primary Completion Date : June 1, 2020
Estimated Study Completion Date : June 1, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Ursodiol

Arms and Interventions
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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


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

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02936596


Contacts
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Contact: Xiaoli Fan, MM +862885422311 13980433451@163.com

Locations
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China, Sichuan
West China Hospital Recruiting
Chengdu, Sichuan, China, 610041
Contact: Xiaoli Fan, MM    +8618008028017    13980433451@163.com   
Contact: Li Yang, MD       yangli_hx@scu.edu.cn   
Sponsors and Collaborators
Xiaoli Fan
Investigators
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Study Chair: Li Yang, MD West China Hospital,Chengdu, Sichuan, China
More Information
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Responsible Party: Xiaoli Fan, Master Degree, West China Hospital
ClinicalTrials.gov Identifier: NCT02936596    
Other Study ID Numbers: OS-1
First Posted: October 18, 2016    Key Record Dates
Last Update Posted: May 4, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis
Liver Cirrhosis
Cholangitis
Cholestasis
Hepatitis, Autoimmune
Liver Cirrhosis, Biliary
Undifferentiated Connective Tissue Diseases
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
 RNA Virus Infections
Bile Duct Diseases
Biliary Tract Diseases
Hepatitis, Chronic
Autoimmune Diseases
Immune System Diseases
Connective Tissue Diseases
Cholestasis, Intrahepatic
Ursodeoxycholic Acid
Immunosuppressive Agents
Cholagogues and Choleretics
Gastrointestinal Agents
Immunologic Factors
Physiological Effects of Drugs