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Phase III Study of HRS-5635 in Nucleos(t)Ide Analogue-suppressed HBeAg-negative Patients With Chronic Hepatitis B

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Recruitment opened Start date changed from estimate of Jun 2026 to Jul 17, 2026 · Secondary endpoints revised (15) · Site details revisedv2 Show 3 more changesShow less
    • Start date changed from estimate of Jun 2026 to Jul 17, 2026
    • Secondary endpoints revised (15)
    • Site details revised

    See this version in full on ClinicalTrials.gov ↗

  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This study is intended to confirm the efficacy, safety, pharmacokinetic (PK) profile, and immunogenicity of HRS-5635 injection as compared to the placebo arm in nucleos(t)ide analogue-suppressed HBeAg-negative patients with chronic hepatitis B. The total duration of the study, including screening (up to 4 weeks), the double-blind treatment stage (60 weeks)，NAs-only treatment stage（12 weeks） and the off-treatment follow-up (24 weeks), is up to approximately 100 weeks at maximum for each participant.
Trial Details
NCT Number NCT07606950
Lead Sponsor Fujian Shengdi Pharmaceutical Co., Ltd.
Conditions Nucleos(t)Ide Analogue-suppressed HBeAg-negative Patients With Chronic Hepatitis B
Enrollment 540 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov