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NCT Number: NCT06238544

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Paroxysmal Nocturnal Hemoglobinuria Anemia Anemia, Hemolytic Bone Marrow Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemoglobinuria, Paroxysmal Myelodysplastic Syndromes

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Beijing, Beijing Municipality, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

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

Treatment and study plan

HRS-5965 tablets

Drug

HRS-5965 tablets until the end of study treatment

HRS-5965 Capsules

Drug

HRS-5965 capsules.

Primary outcomes

  1. Incidence and severity of adverse events.

    Time frame: Every six months,for about 3 years

Secondary outcomes

  1. Proportion of participants achieving sustained hemoglobin levels ≥ 12 g/dL in the absence of red blood cell transfusions was assessed every half a year during treatment..

    Time frame: Every six months ,for about 3 years

  2. Proportion of participants who remain free from transfusions was assessed every half a year during treatment..

    Time frame: Every six months,for about 3 years

  3. Rate of breakthrough hemolysis was assessed every half a year during treatment

    Time frame: Every six months,for about 3 years

  4. Proportion of participants with Major Adverse Vascular Events MAVEs.

    Time frame: Every six months,for about 3 years

  5. Plasma concentration of HRS-5965.

    Time frame: Start of Treatment to end of study，for about 3 years

Sponsors and collaborators

Lead sponsor

Chengdu Suncadia Medicine Co., Ltd.

Industry

Registry information

Official study title

An Open Label, Multicenter Study to Evaluate the Long-term Safety and Tolerability of HRS-5965 in Patients With Paroxysmal Nocturnal Hemoglobinuria

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Feb 2, 2024
Registry last updated
Dec 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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