Efficacy and Safety of HSK39297 in Anti-C5 Treated PNH Patients With Anemia

StatusCompleted
PhasePhase 3
Started

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Record History

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  1. Primary endpoint revisedv3 Show 5 more changesShow less
    • Trial status: Recruiting to Completed
    • Enrollment target: estimated 32 to confirmed 36
    • Primary completion date changed from estimate of Dec 25, 2025 to Dec 23, 2025
    • Study completion date changed from estimate of Jan 8, 2026 to Jan 5, 2026
    • Site details revised at 2 of 2 sites
  2. Secondary endpoints revised (8)
    • Study title revised
    v2
  3. Study First Submitted
  • 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.
The purpose of this study is to evaluate the efficacy of HSK39297 tablets in paroxysmal nocturnal hemoglobinuria (PNH) patients with anemia after stable treatment of anti-C5 antibody.
Trial Details
NCT Number NCT07052838
Lead Sponsor Haisco Pharmaceutical Group Co., Ltd.
Conditions
(from sponsor)		 Paroxysmal Nocturnal Haemoglobinuria (PNH)
Related terms Hemoglobinuria, Paroxysmal
Enrollment 36 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov