A Phase III Study to Evaluate the Efficacy and Safety of HSK39297 in Patients With Paroxysmal Nocturnal Hemoglobinuria Who Are Naive to Complement Inhibitor Therapy
NCT ID: NCT06799546
Last Updated: 2025-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
73 participants
INTERVENTIONAL
2025-02-13
2025-11-05
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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HSK39297 tablets
HSK39297 tablets
200mg QD for 24 weeks
Eculizumab Injection
Eculizumab Injection
Eculizumab Injection for 24 weeks
Interventions
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HSK39297 tablets
200mg QD for 24 weeks
Eculizumab Injection
Eculizumab Injection for 24 weeks
Eligibility Criteria
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Inclusion Criteria
2. Diagnosis of PNH based on flow cytometry with clone size \> 10% by granulocytes;
3. Have not received complement inhibitor treatment;
4. Blood LDH values \> 1.5 ×upper limit of the normal range (ULN) ;
5. Hemoglobin level \< 10 g/dL at screening.
Exclusion Criteria
2. Active primary or secondary immunodeficiency;
3. History of splenectomy, bone marrow/ hematopoietic stem cell or solid organ transplants;
4. History of recurrent invasive infections caused by encapsulated organisms( e.g. meningococcus or pneumococcus) or Mycobacterium tuberculosis;
5. Patients with laboratory evidence of bone marrow failure (reticulocytes \< 100x10\^9/L, or platelets \< 30x10\^9/L or neutrophils \< 0.5x10\^9/L) ;
6. Active systemic infection within 2 weeks prior to study drug administration;
7. History of serious comorbidities that have been determined to be unsuitable for participation in the study.
8. Pregnant or Lactating women.
18 Years
75 Years
ALL
No
Sponsors
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Haisco Pharmaceutical Group Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
The First Affiliated Hospital, College of Medicine, Zhejiang University
Hangzhou, Zhejiang, China
Countries
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Other Identifiers
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HSK39297-301
Identifier Type: -
Identifier Source: org_study_id