Last updated: June 16, 2021
Sponsor: West China Hospital
Overall Status: Active - Recruiting
Phase
4
Condition
Hepatitis
Gall Bladder Disorders
Liver Disease
Treatment
N/AClinical Study ID
NCT04376528
OS-3
Ages 18-70 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Patients aged 18-70 years;
- Diagnosed with PBC-AIH overlap syndrome according to Paris criteria;
- Patients have a nonresponse to azathioprine;
- The WBC count ≥2.5x10^9/L and platelet count ≥50x10^9/L.
- Agreed to participate in the trial, and assigned informed consent;
Exclusion
Exclusion Criteria:
- The presence of hepatitis A, B, C, D, or E virus infection;
- Patients with presence of serious decompensated cirrhosis;
- Patients have a history of glucocorticoid or immunosuppressant medication beforeenrollment;
- Liver damage caused by other reasons: such as primary sclerosing cholangitis,non-alcoholic steatohepatitis, drug induced liver disease or Wilson's disease.
- Pregnant and breeding women and women of childbearing age in need of reproduction
- Severe disorders of other vital organs, such as severe heart failure, cancer;
- Patients with presence of renal insufficiency;
- Parenteral administration of blood or blood products within 6 months before screening;
- Recent treatment with drugs having known liver toxicity;
- Taken part in other clinic trials within 6 months before enrollment.
- Patients who are allergic to these drugs;
- Uncontrolled infection and hypertension ;
Study Design
Total Participants: 89
Study Start date:
June 16, 2021
Estimated Completion Date:
December 30, 2021
Connect with a study center
WestChina Hospital
Chengdu, Sichuan 610041
ChinaActive - Recruiting
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