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 @ 3:55 PM
Ignite Modification Date:
2025-12-24 @ 3:55 PM
NCT ID:
NCT04613492
Eligibility Criteria:
Inclusion Criteria:
1. Participant must be at least 18 years old at signing of informed consent.
2. Body weight \> 35 kg at screening.
Exclusion Criteria:
1 Primary central nervous system (CNS) disease is excluded, as well as untreated or uncontrolled metastatic CNS involvement, leptomeningeal disease, or cord compression.
NOTE: CNS disease that has been treated and stable/controlled for at least 3 months is permitted. Participants with CNS disease controlled via systemic steroids are not permitted.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
101 Years
Study:
NCT04613492
Study Brief:
Protocol Section:
NCT04613492