Chronic hepatitis B
Conditions
Interventions
Pradefovir group:None
Control group:None
Sponsors
The first affiliated hospital of anhui medical university
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Age 18–65 years (inclusive), sex unrestricted; 2.Meet the diagnostic criteria for chronic hepatitis B (documented HBsAg or HBV DNA positivity for >6 months, or confirmed by liver biopsy); 3.Meet the criteria for nucleos(t)ide analogue (NA)–experienced patients considered favorable for interferon-induced clinical cure, i.e., HBsAg <1,500 IU/mL, HBeAg negative, and HBV DNA undetectable; 4.Previously received antiviral therapy with tenofovir alafenamide (TAF) for =12 months; 5.Any prior interferon therapy (including pegylated and non-pegylated) must have ended =6 months before the baseline visit; 6.Agree to use effective non-pharmacologic contraception during the study; 7.No contraindications to interferon therapy, and willing to participate with written informed consent.
Exclusion criteria
Exclusion criteria: (1)Evidence suggestive of hepatocellular carcinoma or serum alpha-fetoprotein (AFP) >100 µg/L. (2) Clear signs of hepatic decompensation, such as ascites, hepatic encephalopathy, or bleeding from ruptured esophagogastric varices. (3) Platelet count (PLT) 2.5 × the upper limit of normal (ULN). (4) Coinfection with hepatitis C or D virus, HIV/AIDS, autoimmune hepatitis, or active hepatitis due to other causes. (5) History of hypersensitivity to nucleosides or nucleos(t)ide analogues. (6) Concomitant severe cardiopulmonary dysfunction, advanced malignancy, central nervous system disorders (e.g., a history of seizures), or other significant systemic diseases. (7) Concomitant neurologic or psychiatric disorders that preclude cooperation, or unwillingness to cooperate. (8) Pregnant or breastfeeding women, or those planning conception in the near term. (9) Use within the past 3 months, or current use, of drugs that are strong or weak inhibitors of CYP3A4 or P-gp (e.g., ketoconazole, erythromycin, itraconazole), as well as strong inducers of CYP3A4 or P-gp (e.g., rifampin, phenytoin). (10) Inability to provide consent after enrollment or unlikely to complete 1 year of follow-up. (11) Deemed unsuitable for participation at the investigator’s discretion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Quantitative HBV five-marker serologic panel;Hepatitis B virus DNA; | — |
Secondary
| Measure | Time frame |
|---|---|
| liver function tests;Drug-related adverse events; | — |
Countries
China
Contacts
Public Contactyufenggao
The first affiliated hospital of anhui medical university
Outcome results
None listed