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Completed
NCT07815418
The Relationship Between Novel Virological Indicators and Treatment With Different Nucleotide Analogues and the Prognosis of HBV-ACLF Patients
Conditions: Acute-on-Chronic Liver Failure (ACLF), hepatitisB, Treatment
Sex: All
Ages: 18 Years – 70 Years
Healthy volunteers: No
Enrollment: 235
Sponsor: Tongji Hospital
Location: Tongji Hospital Wuhan Hubei
Summary
This is an observational study. This study mainly explores the dynamic changes of HBV RNA and HBcrAg during the treatment of HBV-ACLF, as well as the safety of entecavir (ETV), tenofovir alafenamide (TAF) and tenofovir amibufenamide (TMF) during the treatment process, and evaluates the differences in patient prognosis among the three drugs.
Eligibility Criteria
Inclusion Criteria:
1. Age 18-70;
2. Hepatitis B surface antigen positive ≥ 6 months;
3. TBil\>5mg/dl or 85 μ mol/L; INR ≥ 1.5 or PTA \< 40%; Clinical manifestation of ascites and/or hepatic encephalopathy within four weeks of onset (According to the diagnostic criteria recommended by the Asian Pacific association for the study of the liver (APASL))
Exclusion Criteria:
1. Patients with malignant liver tumors and other tumors;
2. Pregnant or lactating women;
3. Patients with liver diseases caused by combined hepatitis C virus infection, hepatitis E virus infection, autoimmune hepatitis, poisoning, drug-induced liver damage, acute variceal bleeding, alcoholic liver disease, and genetic metabolic liver disease;
4. Patients with human immunodeficiency virus infection or other immunodeficiency diseases;
5. Patients with other organ dysfunction or failure;
6. Combined using more than one NAs drug
Source: ClinicalTrials.gov (NCT07815418). StuddyBuddy aggregates publicly available trial information.