Efficacy and Safety of HSK39297 in Anti-C5 Treated PNH Patients With Anemia
NCT ID: NCT07052838
Last Updated: 2025-12-16
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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RECRUITING
PHASE3
32 participants
INTERVENTIONAL
2025-05-12
2026-01-08
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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HSK39297
HSK39297 tablets
200mg QD
Interventions
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HSK39297 tablets
200mg QD
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
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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Central Contacts
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Facility Contacts
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Other Identifiers
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HSK39297-302
Identifier Type: -
Identifier Source: org_study_id