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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
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:     Xiaoli Fan, MM
Address: 
Telephone: +8618008028017
Email: 13980433451@163.com
Affiliation: 
Name:     Xiaoli Fan, MM
Address: 
Telephone: +862885422311
Email: 13980433451@163.com
Affiliation: 
Name:     Li Yang, MD
Address: 
Telephone:
Email:
Affiliation:  West China Hospital,Chengdu, Sichuan, China
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
Cholangitis
Cholestasis
Hepatitis, Autoimmune
Liver Cirrhosis, Biliary
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]
Alkaline phosphatase(ALP) [Time Frame: Week 2 and Month 1, 3, 6]
Aspartate transaminase(AST) [Time Frame: Week 2 and Month 1, 3, 6]
Direct bilirubin(DB) [Time Frame: Week 2 and Month 1, 3, 6]
Globin(GLB) [Time Frame: Week 2 and Month 1, 3, 6]
Glutamyltransferase(GGT) [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]
Secondary ID(s)
OS-1
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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