A Study to Evaluate the Efficacy and Safety of HSK39297 in Patients With Paroxysmal Nocturnal Hemoglobinuria（PNH）

Korábbi kezelés

• Active systemic infection within 2 weeks prior to study drug administration;

Más betegség

• History of splenectomy, bone marrow/ hematopoietic stem cell or solid organ transplants;
• History of recurrent invasive infections caused by encapsulated organisms( e.g. meningococcus or pneumococcus) or Mycobacterium tuberculosis;
• History of serious comorbidities that have been determined to be unsuitable for participation in the study.

Laborértékek

• Patients with laboratory evidence of bone marrow failure (reticulocytes < 100x10\^9/L, or platelets < 30x10\^9/L or neutrophils < 0.5x10\^9/L) ;

Egyéb

• Hereditary or acquired complement deficiency;
• Active primary or secondary immunodeficiency;
• Pregnant or Lactating women.

• Male and female participants ≥ 18 years of age;
• Diagnosis of PNH based on flow cytometry with clone size > 10% by granulocytes;
• Have not received complement inhibitor treatment;
• Blood lactate dehydrogenase(LDH) values > 1.5 ×upper limit of the normal range (ULN) ;
• Hemoglobin level < 100 g/L during the screening period.