Remission Induction of Primary Biliary Cholangitis-autoimmune Hepatitis Overlap Syndrome

• Register: ClinicalTrials.gov
• Last refreshed on: 8 November 2021
• Main ID: NCT02936596
• Date of registration: 15/10/2016
• Prospective Registration: Yes
• Primary sponsor: Xiaoli Fan
• Public title: Remission Induction of Primary Biliary Cholangitis-autoimmune Hepatitis Overlap Syndrome
• Scientific title: Biochemical Response of Primary Biliary Cholangitis-autoimmune Hepatitis Overlap Syndrome Induced by Ursodeoxycholic Acid Only or Combination Therapy of Immunosuppressive Agents
• Date of first enrolment: December 2016
• Target sample size: 53
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT02936596
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

China

Contacts

• Name: Li Yang, MD
• Affiliation: West China Hospital,Chengdu, Sichuan, China

• Name: Xiaoli Fan, MM

• Name: Xiaoli Fan, MM

Key inclusion & exclusion 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 ?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.



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Hepatitis, Autoimmune

Liver Cirrhosis, Biliary

Cholangitis

Cholestasis

Intervention(s)

Drug: Ursodeoxycholic Acid

Drug: Ursodeoxycholic acid combination of immunosuppressive agents

Primary Outcome(s)

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(s)

Alanine transaminase (ALT) [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]

Aspartate transaminase(AST) [Time Frame: Week 2 and Month 1, 3, 6]

Globin(GLB) [Time Frame: Week 2 and Month 1, 3, 6]

Immunoglobulin G(IgG) [Time Frame: Week 2 and Month 1, 3, 6]

Side effects [Time Frame: Evaluation of side effects during the study period(6 months)]

Total bilirubin(TB) [Time Frame: Week 2 and Month 1, 3, 6]

Glutamyltransferase(GGT) [Time Frame: Week 2 and Month 1, 3, 6]

Secondary ID(s)

OS-1

Source(s) of Monetary Support

Please refer to primary and secondary sponsors