Status:
COMPLETED
A Study to Evaluate the Efficacy and Safety of HSK39297 in Patients With Paroxysmal Nocturnal Hemoglobinuria（PNH）
Lead Sponsor:
Haisco Pharmaceutical Group Co., Ltd.
Conditions:
Paroxysmal Nocturnal Hemoglobinuria (PNH)
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is a multicenter, randomized, open-label phase 2 study. Adult Patients with paroxysmal nocturnal hemoglobinuria naïve to complement inhibitor therapy were included. Subjects were treated with HSK...
Eligibility Criteria
Inclusion
- 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
- 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 \< 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 for participation in the study.
- Pregnant or Lactating women.
Key Trial Info
Start Date :
July 17 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 2 2025
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT06561841
Start Date
July 17 2024
End Date
April 2 2025
Last Update
June 29 2025
Active Locations (1)
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1
The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China, 210029