Efficacy and Safety of HSK39297 in Anti-C5 Treated PNH Patients With Anemia (NCT07052838) | Clinical Trial Compass
CompletedPhase 3
Efficacy and Safety of HSK39297 in Anti-C5 Treated PNH Patients With Anemia
China36 participantsStarted 2025-05-12
Plain-language summary
The purpose of this study is to evaluate the efficacy of HSK39297 tablets in paroxysmal nocturnal hemoglobinuria (PNH) patients with anemia after stable treatment of anti-C5 antibody.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion Criteria:
* Age ≥ 18 and ≤ 75 years, Male and female patients.
* Diagnosis of PNH based on flow cytometry showing \>10% granulocyte clone size during the screening period.
* Stable use of Anti-C5 antibody at least 6 months prior to enrollment.
* Hemoglobin level \< 10 g/dL at screening.
Exclusion Criteria:
* 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.
* Patients with laboratory evidence of bone marrow failure (reticulocytes \< 100x109/L, or platelets \< 30x109/L or neutrophils \< 0.5x109/L).
* Active systemic infection within 2 weeks prior to study drug administration.
* History of serious comorbidities that have been determined to be unsuitable for participation in the study.
* Pregnant or Lactating women.
What they're measuring
1
Proportion of participants achieving hemoglobin levels ≥ 120 g/L at least on three out of four measurements in the absence of red blood cell transfusions