NCT03903796

Study of the Efficacy and Safety of HS-10234 in Patients With Chronic Hepatitis B Virus Infection

A Phase 3, Randomized, Multicenter, Double-blind, Double-dummy, Parallel-controlled Study to Evaluate the Safety and Efficacy of HS-10234 25 mg QD Versus TDF 300 mg QD for the Treatment of Patients With HBeAg+/- Chronic HBV Infection.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 963 (actual)
• Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Chronic HBV Infection

Interventions

Type	Name	Description
DRUG	HS-10234	Drug: HS-10234 HS-10234 25mg will administer orally once daily Drug: TDF placebo TDF placebo 300mg will administer orally once daily
DRUG	TDF	Drug: TDF TDF 300mg will administer orally once daily Drug: HS-10234 placebo HS-10234 placebo 25mg will administer orally once daily

Timeline

• Start date: 2018-08-16
• Primary completion: 2020-05-31
• Completion: 2024-06-07
• First posted: 2019-04-04
• Last updated: 2024-12-17

Locations

1 site across 1 country: China