Remission Induction of Primary Biliary Cholangitis-autoimmune Hepatitis Overlap Syndrome

Xiaoli Fan

Status: Unknown

Conditions: Hepatitis, Autoimmune; Liver Cirrhosis, Biliary; Cholangitis; Cholestasis

Treatments: Drug: Ursodeoxycholic Acid; Drug: Ursodeoxycholic acid combination of immunosuppressive agents

Study type: Interventional

Funder types: Other

Identifiers

NCT02936596

OS-1

Details and patient eligibility

About

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

Enrollment: 53 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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53 participants in 2 patient groups

Ursodeoxycholic acid + immunosuppressive agents group

Experimental group

Description:

Ursodeoxycholic acid + immunosuppressive agents

Treatment:

Drug: Ursodeoxycholic acid combination of immunosuppressive agents

Ursodeoxycholic acid group

Active Comparator group

Description:

Ursodeoxycholic acid

Treatment:

Drug: Ursodeoxycholic Acid