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Long-term Safety and Tolerability of HRS-5965 in Patients With Paroxysmal Nocturnal Hemoglobinuria

Long-term Safety and Tolerability of HRS-5965 in Patients With Paroxysmal Nocturnal Hemoglobinuria

Recruiting
18 years and older
All
Phase 2

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Overview

This is a multicenter, single-arm, open-label study. Patients with Paroxysmal Nocturnal Hemoglobinuria who had previously received and completed the HRS-5965 study well included. All eligible subjects received HRS-5965 tablets or capsules until the end of treatment in this study.

Eligibility

Inclusion Criteria:

  1. Patients who have previously received and completed HRS-5965 study treatment, and are judged by the investigator to have treatment benefit and may benefit from continued treatment of HRS-5965 and patients in the control group of who received eculizumab treatment.

Exclusion Criteria:

  1. Known or suspected hereditary or acquired complement deficiency;
  2. History of infection with capsular bacteria (e.g., meningococcus, pneumococcus, etc.)

Study details
    Paroxysmal Nocturnal Hemoglobinuria

NCT06238544

Chengdu Suncadia Medicine Co., Ltd.

15 October 2025

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