Status:
COMPLETED
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
Lead Sponsor:
Chengdu Suncadia Medicine Co., Ltd.
Conditions:
Paroxysmal Nocturnal Hemoglobinuria
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
A study of the efficacy and safety of HRS-5965 capsules compared to eculizumab for 24 weeks in patients with PNH.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 25 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2025
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT06593938
Start Date
October 25 2024
End Date
July 31 2025
Last Update
September 11 2025
Active Locations (2)
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1
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China, 100730
2
The Blood Disease Hospital of the Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, China, 300020