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A Multicenter, Randomized, Open, Parallel-designed Study to Evaluate the Efficacy and Safety of HRS-5635 Injection Alone or in Combination With Other Agents in Patients Treated for Chronic Hepatitis B

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated November 17, 2025 (before its estimated August 30, 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Primary endpoints: 2 to 4 Enrollment target: 303 to 369 · Interventions: HRS-5635 Injection (Drug), HRS-5635 Injection (Drug), HRS-5635 Injection (Drug), HRS-5635 Injection (Drug), HRS-5635 Injection (high dose)… to HRS-5635 Injection (Drug), HRS-5635 Injection (Drug), HRS-5635 Injection (Drug), HRS-5635 Injection (Drug), HRS-5635 Injection (Drug)… · Study arms: 7 to 9v6 Show 3 more changesShow less
    • Enrollment target: 303 to 369
    • Interventions: HRS-5635 Injection (Drug), HRS-5635 Injection (Drug), HRS-5635 Injection (Drug), HRS-5635 Injection (Drug), HRS-5635 Injection (high dose)… to HRS-5635 Injection (Drug), HRS-5635 Injection (Drug), HRS-5635 Injection (Drug), HRS-5635 Injection (Drug), HRS-5635 Injection (Drug)…
    • Study arms: 7 to 9

    See this version in full on ClinicalTrials.gov ↗

  2. Re-verified, no change to tracked fieldsv5
  3. Enrollment target: 165 to 303 Primary completion date: May 15, 2026 to Aug 30, 2026 · Completion date: Sep 19, 2026 to Jan 19, 2027 · Start date: Jun 14, 2024 to Jun 6, 2024 · 3 morev4 Show 6 more changesShow less
    • Primary completion date: May 15, 2026 to Aug 30, 2026
    • Completion date: Sep 19, 2026 to Jan 19, 2027
    • Start date: Jun 14, 2024 to Jun 6, 2024
    • Interventions: HRS-5635 Injection (Drug), HRS-5635 Injection (Drug), HRS-5635 Injection (Drug), HRS-5635 Injection (Drug) to HRS-5635 Injection (Drug), HRS-5635 Injection (Drug), HRS-5635 Injection (Drug), HRS-5635 Injection (Drug), HRS-5635 Injection (high dose)…
    • Secondary endpoints: 8 to 10
    • Study arms: 4 to 7

    See this version in full on ClinicalTrials.gov ↗

  4. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Jul 1, 2024 to Jun 14, 2024 · Site details revisedv3 Show 2 more changesShow less
    • Start date changed from estimate of Jul 1, 2024 to Jun 14, 2024
    • Site details revised
  5. Enrollment target: 150 to 165 Interventions: HRS-5635 Injection (Drug), HRS-5635 Injection (Drug), HRS-5635 Injection (Drug) to HRS-5635 Injection (Drug), HRS-5635 Injection (Drug), HRS-5635 Injection (Drug), HRS-5635 Injection (Drug) · Study arms: 3 to 4v2 Show 2 more changesShow less
    • Interventions: HRS-5635 Injection (Drug), HRS-5635 Injection (Drug), HRS-5635 Injection (Drug) to HRS-5635 Injection (Drug), HRS-5635 Injection (Drug), HRS-5635 Injection (Drug), HRS-5635 Injection (Drug)
    • Study arms: 3 to 4
  6. 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.
A multicenter, randomized, open, parallel-designed Phase II study to evaluate the efficacy and safety of HRS-5635 injection alone or in combination with other agents in patients treated for chronic hepatitis B.
Trial Details
NCT Number NCT06425341
Lead Sponsor Fujian Shengdi Pharmaceutical Co., Ltd.
Conditions Chronic Hepatitis B
Enrollment 369 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov