Chronic Hepatitis B
Conditions
Brief summary
UsingTAF as the control, the nvestigators aim to further explore the efficacy and safety of different dosages of HTS in the treatment of patients with chronic hepatitis B; ultimately, the nvestigators determine the optimal recommended dosage of HTS to provide a basis for Phase III confirmatory clinical research.
Interventions
DRUGHTS 20mg
Once daily, administered concomitantly with one TAF placebo tablet per dose, taken once daily with or within 30 minutes after a meal.
DRUGHTS 30mg
Once daily, administered concomitantly with one TAF placebo tablet per dose, taken once daily with or within 30 minutes after a meal.
DRUGHTS 40mg
Once daily, administered concomitantly with one TAF placebo tablet per dose, taken once daily with or within 30 minutes after a meal.
DRUGTAF 25mg
Once daily, administered concomitantly with one HTS placebo tablet per dose, taken once daily with or within 30 minutes after a meal.
Sponsors
Xi'an Xintong Pharmaceutical Research Co.,Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1）Age between 18 to 65 years old (inclusive), regardless of gender. 2) Meets diagnostic criteria for chronic hepatitis B (documented HBsAg positivity or HBV DNA positivity for more than 6 months, or confirmed by liver biopsy histopathology). 3)No prior treatment with any nucleos(t)ide analogue oral antiviral therapy; or, previous treatment with any nucleos(t)ide analogue must have ended at least 6 months prior to baseline. 4\) Any interferon therapy (both pegylated and non-pegylated) must be completed at least 1 year prior to baseline visit. 5\) Willing to use effective non-pharmacological contraception during the trial period.
Exclusion criteria
1. Hypersensitive to the study drug, its metabolites or any excipient in its formula; 2. With previous or present clinical hepatic decompensation (e.g., ascites, hepatic encephalopathy or varicose vein haemorrhage) 3. Complicated with liver diseases, including chronic alcoholic hepatitis, drug-induced hepatitis, etc. 4. Complicated with HCV, HIV or HDV infections 5. Documented resistance to the antiviral drug (Tenofovir). 6. Any cardiovascular, hematologic,pulmonary or nervous diseases deemed serious by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of participants with treatment-related adverse events of the Optimal Dosing Regimen as assessed by CTCAE v5.0 | through study completion, an average of 1 year |
Countries
China
Outcome results
None listed