Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:52 PM
Ignite Modification Date:
2025-12-24 @ 6:52 PM
NCT ID:
NCT06051357
Eligibility Criteria:
Inclusion Criteria:
1. Diagnosis of PNH confirmed by flow cytometry with clone size ≥ 10%.
2. Have not received complement inhibitor therapy ;
3. LDH \> 1.5×ULN;
4. Hemoglobin level \< 10 g/dL.
Exclusion Criteria:
1. Known or suspected hereditary or acquired complement deficiency;
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06051357
Study Brief:
Protocol Section:
NCT06051357