Phase
Condition
Hemoglobinuria, Paroxysmal
Anemia
Proteinuria
Treatment
HSK39297
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
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.
Exclusion
Exclusion Criteria:
Hereditary or acquired complement deficiency;
Active primary or secondary immunodeficiency;
History of splenectomy, bone marrow/ hematopoietic stem cell or solid organtransplants;
History of recurrent invasive infections caused by encapsulated organisms( e.g.meningococcus or pneumococcus) or Mycobacterium tuberculosis;
Patients with laboratory evidence of bone marrow failure (reticulocytes < 100x10^9/L, or platelets < 30x10^9/L or neutrophils < 0.5x10^9/L) ;
Active systemic infection within 2 weeks prior to study drug administration;
History of serious comorbidities that have been determined to be unsuitable forparticipation in the study.
Pregnant or Lactating women.
Study Design
Connect with a study center
The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu 210029
ChinaActive - Recruiting
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