The primary objective of this study is to compare the safety and efficacy of HS-10234 versus tenofovir disoproxil fumarate (TDF) in treatment-naive and treatment-experienced adults with chronic hepatitis B virus (HBV) infection.
This is a phase 3, randomized, multicenter, double-blind, double-dummy, parallel-controlled, non-inferiority trial to evaluate the safety and efficacy of HS-10234 25 mg qd versus TDF 300 mg qd. Patients with chronic HBV infection who are positive or negative for the hepatitis B e antigen (HBeAg) will be randomly assigned (2:1) to receive either 25 mg HS-10234 or 300 mg TDF with matching placebo. Randomization will be done by a computer-generated allocation sequence stratified by plasma HBV DNA concentration (HBV DNA\< 8 log10IU/mL;HBV DNA ≥8 log10IU/mL) and previous treatment experience (treatment-naive and treatment-experienced). All patients will receive 144 weeks of antiviral therapy. After 96 weeks of double-blind treatment, all subjects will be eligible to receive open-label HS-10234 until 144 weeks. The primary efficacy endpoint is the proportion of patients with HBV DNA less than 20 IU/mL at week 48 in all patients who are randomly assigned and received at least one dose of study drug using a missing-equals-failed approach. Key pre-specified safety endpoints are bone and renal parameters at week 48. Other pre-specified endpoints include viral suppression, serologic response, normalization of alanine aminotransferase (ALT) levels and the emergence of resistance mutations at week 48, 96 and 144.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
963
The First Hospital of Jilin University
Changchun, Jilin, China
Evaluation the percentage of Participants with Hepatitis B Virus (HBV) DNA < 20 IU/mL
The primary efficacy endpoint was the proportion of patients with HBV DNA \< 20 IU/mL at week 48 in all patients who are randomly assigned and received HS-10234 25 mg or TDF 300 mg. The safety and tolerance were also observed in two treatment groups.
Time frame: Week 48
Evaluation the percent Change from Baseline in Hip BMD
Percent Change from Baseline in Hip Bone Mineral Density (BMD) at Week 48
Time frame: Week 48
Evaluation the percent Change from Baseline in Spine BMD
Percent Change from Baseline in Spine BMD at Week 48
Time frame: Week 48
Evaluation the change from Baseline in Serum Creatinine
Change from Baseline in Serum Creatinine at Week 48
Time frame: Week 48
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.