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A Multicenter Study of AHB-137 Injection Combined With Other Hepatitis B Drugs

StatusRecruiting
PhasePhase 2
Started
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Record History

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  1. Minor Trial sites expanded: 1 → 14 locationsv5
  2. Notable Trial status: Active, Not Recruiting to Recruitingv4 Show 7 more changesShow less
    • Enrollment target: 127 to 200
    • Primary completion date: Jan 1, 2027 to Jul 15, 2027
    • Study completion date: May 1, 2027 to Jan 15, 2028
    • Start date: May 30, 2025 to Jun 8, 2025
    • Secondary endpoints: 14 to 15
    • Site details revised
    • Study arms: 4 to 5
  3. Minor Secondary endpoints: details revised at 1 of 14 entriesv3
  4. Minor Trial status: Recruiting to Active, Not Recruitingv2 Show 4 more changesShow less
    • Enrollment target: estimated 120 to confirmed 127
    • Interventions: AHB-137 (Drug), AHB-137 and Hepatitis B vaccine (Drug), AHB-137 and Peg-IFN (Drug), AHB-137 and Peg-IFN (Drug) to AHB-137 (Drug), Hepatitis B Vaccine (Drug), Peg-IFN (Drug)
    • Secondary endpoints revised (14)
    • Site details revised
  5. Minor 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 is a randomized, open-label, multicenter phase II study to evaluate the efficacy and safety of AHB-137 injection in combination with other hepatitis B drugs in participants with HBeAg-negative CHB treated with NAs.
Trial Details
NCT Number NCT07069569
Lead Sponsor Ausper Biopharma Co., Ltd.
Conditions
(from sponsor)
Chronic Hepatitis B
Related terms Hepatitis B, Chronic
Enrollment 200 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov