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 @ 9:33 PM
Ignite Modification Date:
2025-12-24 @ 9:33 PM
NCT ID:
NCT00867932
Eligibility Criteria:
Inclusion Criteria:
* Participants between 2 and 17 years of age;
* Diagnosed with PNH;
* Participants with ≥ 5% glycosylphosphatidylinositol-deficient red blood cells or granulocytes as confirmed by flow cytometry;
* Participants must have shown evidence of hemolytic anemia as documented by lactate dehydrogenase greater than the upper limit of normal or at least 1 transfusion in the past 2 years for anemia or anemia related symptoms;
* Written informed consent from a parent/guardian;
* Negative pregnancy test for females of child bearing potential at screening;
* Sexually active females must have documented a reliable and medically approved method of contraception;
* Participant must have been vaccinated against N. men, S. pneumo, and H. influ at least 14 days prior to study drug initiation or received antibiotics for 14 days after the vaccinations.
Exclusion Criteria:
* Prior eculizumab treatment;
* Presence or suspicion of active bacterial infection at baseline;
* Participation in another concurrent clinical study within at least 30 days prior to screening;
* History of meningococcal/pneumococcal/gonococcal disease;
* Pregnant, breast feeding, or intending to conceive during the study including the safety follow-up visits;
* Any other condition that could increase the participant's risk or confound the outcome of the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Years
Maximum Age:
17 Years
Study:
NCT00867932
Study Brief:
Protocol Section:
NCT00867932