Clinical trial NCT02936596: Remission Induction of Primary Biliary Cholangitis-autoimmune Hepatitis Overlap Syndrome
Official title: Biochemical Response of Primary Biliary Cholangitis-autoimmune Hepatitis Overlap Syndrome Induced by Ursodeoxycholic Acid Only or Combination Therapy of Immunosuppressive Agents
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hepatitis, Autoimmune
Cholangitis
Liver Cirrhosis, Biliary
Cholestasis
Lead sponsor: West China Hospital
Sponsor class: OTHER
First posted: 2016-10-18
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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.

Primary outcomes:
measure: Percent of patients that achieve biochemical remission of autoimmune hepatitis(AIH)
timeFrame: Month 6 during treatment with ursodeoxycholic acid only or combination therapy of immunosuppressive agents
Secondary outcomes:
measure: Alanine transaminase (ALT)
timeFrame: Week 2 and Month 1, 3, 6
measure: Aspartate transaminase(AST)
timeFrame: Week 2 and Month 1, 3, 6
measure: Immunoglobulin G(IgG)
timeFrame: Week 2 and Month 1, 3, 6
measure: Globin(GLB)
timeFrame: Week 2 and Month 1, 3, 6
measure: Total bilirubin(TB)
timeFrame: Week 2 and Month 1, 3, 6
measure: Direct bilirubin(DB)
timeFrame: Week 2 and Month 1, 3, 6
measure: Alkaline phosphatase(ALP)
timeFrame: Week 2 and Month 1, 3, 6
measure: Glutamyltransferase(GGT)
timeFrame: Week 2 and Month 1, 3, 6
measure: Side effects
timeFrame: Evaluation of side effects during the study period(6 months)
Other outcomes:
Locations:
city: Chengdu
country: China
facility: West China Hospital
state: Sichuan
Study officials:
affiliation: West China Hospital,Chengdu, Sichuan, China
name: Li Yang, MD
role: STUDY_CHAIR
References: