Phase
Condition
Hemoglobinuria, Paroxysmal
Bone Marrow Disorder
Anemia
Treatment
HRS-5965 capsule
Eculizumab Injection
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
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
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 ofHRS-5965;
History of infection with capsular bacteria (e.g., meningococcus, pneumococcus,etc.)
Positive of HIV, HBsAg or HCVAb.
Study Design
Connect with a study center
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing 100730
ChinaSite Not Available
The Blood Disease Hospital of the Chinese Academy of Medical Sciences
Tianjin, Tianjin 300020
ChinaSite Not Available
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