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 @ 3:01 AM
Ignite Modification Date:
2025-12-25 @ 3:01 AM
NCT ID:
NCT05274633
Eligibility Criteria:
Inclusion Criteria:
* Body weight of 10 kilogram or above
* Hemolysis with clinical symptom(s) indicative of high disease activity
* Documented diagnoses 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%
* Clinically stable after having been treated with eculizumab for at least the past 6 months
* Participant already assigned to ravulizumab treatment as a specific therapeutic strategy within the current routine clinical practice (this decision has to be made independently and before the enrolment of the participant in the study)
* Vaccinated against Neisseria meningitidis (according to Summary of Product Characteristics) \< 3 years before dosing or at least 2 weeks prior to initiating ravulizumab unless the risk of delaying ravulizumab therapy outweighs the risk of developing a meningococcal infection
* Signed written informed and privacy consent prior to study participation
Exclusion Criteria:
* History of hematopoietic stem cell transplantation (evaluated at baseline)
* Known pregnant or breastfeeding participant (evaluated at baseline)
* Participant unable to read and write in Italian language and to autonomously fill in questionnaires and scales (evaluated at enrolment)
* Participants enrolled in any clinical study receiving experimental treatments for PNH (evaluated at baseline)
* Hypersensitivity to the active substance or to any of the excipient of the study drug.
* Participants with unresolved N. meningitidis infection at treatment initiation
* Participants who are not currently vaccinated against N. meningitidis unless they receive prophylactic treatment with appropriate antibiotics until 2 weeks after vaccination
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05274633
Study Brief:
Protocol Section:
NCT05274633