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:
2025-12-25 @ 3:45 AM
Ignite Modification Date:
2025-12-25 @ 3:45 AM
NCT ID:
NCT04320602
Eligibility Criteria:
Key Inclusion Criteria:
1. Documented diagnosis of PNH, confirmed by high-sensitivity flow cytometry evaluation of red blood cells and white blood cells, with granulocyte or monocyte clone size of ≥ 5%.
2. Received 1200 mg eculizumab every 12 to 16 days (every 2 weeks) for at least 3 months prior to Screening.
3. LDH ≤ 2 x upper limit of normal (ULN) according to central laboratory, at Screening.
4. To reduce the risk of meningococcal infection (Neisseria meningitidis), all participants must be vaccinated against meningococcal infections within 3 years prior to initiating study drug.
5. Body weight ≥ 40 kilograms.
Key Exclusion Criteria:
1. History of major adverse vascular events within 6 months of Day 1.
2. History of bone marrow transplantation.
3. Lymphoma, leukemia, myelodysplastic syndrome, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years.
4. Concomitant use of anticoagulants is prohibited if not on a stable regimen for at least 2 weeks prior to Day 1.
5. Concomitant use of any of the following medications and not on a stable regimen (as judged by the Investigator) for the time period indicated prior to Screening:
* Erythropoietin or immunosuppressants for at least 8 weeks
* Systemic corticosteroids for at least 4 weeks
* Vitamin K antagonists (for example, warfarin) with a stable international normalized ratio level for at least 4 weeks
* Iron supplements or folic acid for 4 weeks
6. Live vaccine(s) within 1 month prior to Screening or plans to receive such vaccines during the study.
7. More than 1 LDH value \> 2 × ULN within the 6 months prior to Day 1.
8. Platelet count \< 30,000/cubic millimeter (30 × 10\^9/Liter \[L\]) at Screening.
9. Absolute neutrophil count \< 500/microliter (0.5 × 10\^9/L) at Screening.
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT04320602
Study Brief:
Protocol Section:
NCT04320602