A Study to Evaluate the Efficacy and Safety of Oral HRS-5965 in Adult Paroxysmal Nocturnal Hemoglobinuria (PNH) Patients Who Are Naive to Complement Inhibitor Therapy
NCT ID: NCT06593938
Last Updated: 2025-09-11
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
76 participants
INTERVENTIONAL
2024-10-25
2025-07-31
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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HRS-5965 capsule
HRS-5965 capsule
HRS-5965 capsule for 24 weeks
Eculizumab Injection
Eculizumab Injection
Eculizumab Injection for 24 weeks
Interventions
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HRS-5965 capsule
HRS-5965 capsule for 24 weeks
Eculizumab Injection
Eculizumab Injection for 24 weeks
Eligibility Criteria
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Inclusion Criteria
2. Have not received complement inhibitor therapy;
3. LDH \> 1.5\*ULN at screening.
4. Hemoglobin level \< 10 g/dL at screening.
Exclusion Criteria
2. Patients with laboratory evidence of bone marrow failure (reticulocytes \<100x109/L; platelets \<30x109/L; neutrophils \<0.5x109/L);
3. Presence or suspicion of a systemic active bacterial, viral, or fungal infection (based on judgment of the investigator) within 2 weeks prior to the first dose of HRS-5965;
4. History of infection with capsular bacteria (e.g., meningococcus, pneumococcus, etc.)
5. Positive of HIV, HBsAg or HCVAb.
18 Years
ALL
No
Sponsors
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Chengdu Suncadia Medicine Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
The Blood Disease Hospital of the Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, China
Countries
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Other Identifiers
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HRS-5965-301
Identifier Type: -
Identifier Source: org_study_id
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