About this trial
This is a multicenter, open-label study to evaluate the long-term safety, tolerability and efficacy of HSK39297. Adult patients with PNH who had previously received and completed HSK39297 study treatment will be included. Eligible subjects can maintain HSK39297 treatment until the end of the study.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients With PNH who have previously received and completed HSK39297 treatment , and According to the researchers' judgment, the benefits of treatment outweigh the risks and may benefit from continued treatment with HSK39297;
Understand the study procedures and methods, voluntarily participate in this trial.
Disqualifiers
Hereditary or acquired complement deficiency;
Active primary or secondary immunodeficiency;
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;
Trial design
Single group
Treatments tested in this trial
HSK39297 tablets
DrugHSK39297 tablets until the end of treatment
Treatment groups
Trial outcomes
Primary outcomes
Incidence and severity of adverse events
Secondary outcomes
Proportion of participants achieving hemoglobin levels ≥ 12 g/dL in the absence of red blood cell transfusions
Change From Baseline in Hemoglobin in the absence of red blood cell transfusions
Proportion of participants who remain free from transfusions
Rate of breakthrough hemolysis (BTH)
Sponsors and contacts
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