Last updated: June 18, 2021
Sponsor: Xiaoli Fan
Overall Status: Active - Recruiting
Phase
4
Condition
Hepatitis
Hepatic Fibrosis
Liver Disease
Treatment
N/AClinical Study ID
NCT04933292
OS-2
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;
- Agreed to participate in the trial, and assigned informed consent;
- The WBC count ≥2.5x10^9/L and platelet count ≥50x10^9/L.
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 disease.
- Pregnant and breeding women;
- Severe disorders of other vital organs, such as severe heart failure, cancer;
- 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.
Study Design
Total Participants: 78
Study Start date:
June 16, 2021
Estimated Completion Date:
May 31, 2022
Connect with a study center
West China Hospital of Sichuan Univerisity
Chengdu, Sichuan 610041
ChinaActive - Recruiting
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