Skip to main content
OpenTrials
Completed

NCT Number: NCT06593938

A Study to Evaluate the Efficacy and Safety of Oral HRS-5965 in Adult Paroxysmal Nocturnal Hemoglobinuria (PNH) Patients Who Are Naive to Complement Inhibitor Therapy

A study of the efficacy and safety of HRS-5965 capsules compared to eculizumab for 24 weeks in patients with PNH.

Completed

Looking for future studies?

Notify Me

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 3

Primary location

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

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosis of PNH confirmed by flow cytometry with clone size > 10%.
  • Have not received complement inhibitor therapy;
  • LDH > 1.5*ULN at screening.
  • Hemoglobin level < 10 g/dL at screening.

Exclusion criteria

  • Known or suspected hereditary or acquired complement deficiency;
  • Patients with laboratory evidence of bone marrow failure (reticulocytes <100x109/L; platelets <30x109/L; neutrophils <0.5x109/L);
  • Presence or suspicion of a systemic active bacterial, viral, or fungal infection (based on judgment of the investigator) within 2 weeks prior to the first dose of HRS-5965;
  • History of infection with capsular bacteria (e.g., meningococcus, pneumococcus, etc.)
  • Positive of HIV, HBsAg or HCVAb.

Treatment and study plan

HRS-5965 capsule

Drug

HRS-5965 capsule for 24 weeks

Eculizumab Injection

Drug

Eculizumab Injection for 24 weeks

Primary outcomes

  1. Proportion of subjects with the hemoglobin levels are ≥ 12 g/dL at least on three out of four measurements in the absence of red blood cell transfusions

    Time frame: 24 weeks

Secondary outcomes

  1. Proportion of subjects with the change from baseline in hemoglobin is ≥ 2 g/dL at least on three out of four measurements in the absence of red blood cell transfusions

    Time frame: 24 weeks

  2. Proportion of subjects who absence of administration of red blood cell transfusions

    Time frame: 24 weeks

  3. Mean change from baseline in hemoglobin

    Time frame: 24 weeks

  4. Mean percent change from baseline in LDH levels

    Time frame: 24 weeks

  5. Mean change from baseline in reticulocyte counts

    Time frame: 24 weeks

  6. Mean change from baseline in FACIT-Fatigue scores

    Time frame: 24 weeks

Sponsors and collaborators

Lead sponsor

Chengdu Suncadia Medicine Co., Ltd.

Industry

Registry information

Official study title

A Multicenter, Randomized, Open-label, Active-comparator Controlled Phase III Study to Evaluate the Efficacy and Safety of HRS-5965 Capsule in Patients With Paroxysmal Nocturnal Hemoglobinuria

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 19, 2024
Registry last updated
Sep 11, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.