Remission Induction of Primary Biliary Cholangitis-autoimmune Hepatitis Overlap Syndrome

Cholestasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02936596
• Other study ID #: OS-1
• Status: Recruiting
• Phase: N/A
• Start date: December 2016
• Est. completion date: June 1, 2022

Study information

• Verified date: May 2021
• Source: West China Hospital
• Contact: Xiaoli Fan, MM
• Phone: +862885422311
• Email: 13980433451[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 53
• Est. completion date: June 1, 2022
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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 ?globulin 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.

Related Conditions & MeSH terms

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

Intervention

Drug:
• Ursodeoxycholic acid combination of immunosuppressive agents
Ursodeoxycholic acid combination of immunosuppressive agents(methylprednisolone with or without azathioprine)
• Ursodeoxycholic Acid
Ursodeoxycholic Acid

Locations

Country	Name	City	State
China	West China Hospital	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
Xiaoli Fan

Country where clinical trial is conducted

China, 

Outcome

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