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 @ 12:01 AM
Ignite Modification Date:
2025-12-25 @ 12:01 AM
NCT ID:
NCT04058158
Eligibility Criteria:
Inclusion Criteria:
* Male or female aged 18 or older
* Eculizumab-naïve patients with PNH
* Presence of the PNH white blood cell (WBC) clone ≥ 10%
* Documented LDH level ≥ 1.5 x ULN at Screening
* History of transfusion for anaemia within 12 months prior to Screening or having PNH-related symptoms at Screening
* Subjects must be vaccinated against Neisseria meningitides
Exclusion Criteria:
* Previous treatment with any complement pathway inhibitors
* ANC ≤ 500/mm3 or Platelet count \< 70,000/mm3
* History of meningococcal disease
* History of bone marrow transplantation
* Known or suspected active bacterial/viral/fungal infection within 30 days
* Stable use of erythropoietic, corticosteroids, heparin, warfarin before randomisation
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04058158
Study Brief:
Protocol Section:
NCT04058158