Chronic Hepatitis B with Low-Level Viremia
Conditions
Interventions
Sponsors
Qingtian County people's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1.Aged 18 to 65 years inclusive; 2.Diagnosed with chronic hepatitis B; 3.Subjects who have received entecavir (ETV) treatment for at least 1 year (or at least 6 months for those with liver cirrhosis) are eligible for inclusion; 4.Subjects with a screening HBV-DNA level of 10 IU/mL <= HBV-DNA < 2000 IU/mL; 5.Must be capable of understanding and providing written informed consent, and willing to receive tenofovir amibufenamide (TMF) treatment continuously for at least 48 weeks.
Exclusion criteria
Exclusion criteria: 1.Co-infection with HAV, HCV, HEV, HIV, or HDV; or concurrent autoimmune hepatitis or drug-induced liver injury; 2.Diagnosis of hepatocellular carcinoma (evidence of HCC) or other malignant tumors; 3.History of using other nucleos(t)ide analogs (NAs) or interferons;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of patients achieving HBV DNA < 10 IU/mL at 48 weeks of treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of subjects (who were initially HBsAg-positive) achieving HBsAg loss and seroconversion to anti-HBs at Weeks 24 and 48 of treatment.;Evaluate the change in creatinine clearance from baseline at Weeks 24 and 48 after switching to TMF treatment;Magnitude of HBV DNA decline at Weeks 24 and 48 of treatment;Proportion of subjects (who were initially HBeAg-positive) achieving HBeAg loss and seroconversion to anti-HBe at Weeks 24 and 48 of treatment;Changes in liver fibrosis scores (APRI and FIB-4) from baseline to Weeks 24 and 48 of treatment;Collect adverse events and clinical laboratory data at Weeks 24 and 48 of TMF treatment, and summarize the data up to Week 48;Proportion of subjects achieving HBV DNA < 10 IU/mL at 24 weeks of treatment;Magnitude of decline in quantitative HBsAg level at Weeks 24 and 48 of treatment;Proportion of subjects achieving ALT normalization (by two criteria: ALT < 40 U/L; or ALT < 30 U/L for males and < 19 U/L for females) at Weeks 24 and 48 of treatment; | — |
Countries
China
Contacts
Public ContactYu Bocun
Qingtian County people's Hospital
Outcome results
None listed