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

Last updated: May 22, 2025
Sponsor: Chengdu Suncadia Medicine Co., Ltd.
Overall Status: Active - Recruiting

Phase

2

Condition

Proteinuria

Anemia

Red Blood Cell Disorders

Treatment

HRS-5965 tablets

HRS-5965 Capsules

Clinical Study ID

NCT06238544
HRS-5965-203
  • Ages > 18
  • All Genders

Study Summary

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 Criteria

Inclusion

Inclusion Criteria:

  1. Patients who have previously received and completed HRS-5965 study treatment, andare judged by the investigator to have treatment benefit and may benefit fromcontinued treatment of HRS-5965 and patients in the control group of who receivedeculizumab treatment.

Exclusion

Exclusion Criteria:

  1. Known or suspected hereditary or acquired complement deficiency;

  2. History of infection with capsular bacteria (e.g., meningococcus, pneumococcus,etc.)

Study Design

Total Participants: 120
Treatment Group(s): 2
Primary Treatment: HRS-5965 tablets
Phase: 2
Study Start date:
February 06, 2024
Estimated Completion Date:
December 31, 2027

Connect with a study center

  • Peking Union Medical College Hospital, Chinese Academy of Medical Sciences

    Beijing, Beijing 100730
    China

    Active - Recruiting

  • The Blood Disease Hospital of the Chinese Academy of Medical Sciences

    Tianjin, Tianjin 300020
    China

    Active - Recruiting

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