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 @ 2:07 AM
Ignite Modification Date:
2025-12-25 @ 2:07 AM
NCT ID:
NCT04513860
Eligibility Criteria:
INCLUSION CRITERIA
1. Patients currently enrolled in one of the following SK life science studies: YKP3089C013, YKP3089C017 or YKP3089C021.
2. Patient who is currently pregnant and enrolled in one of the following SK life science studies: YKP3089C013, YKP3089C017 or YKP3089C021 may enter the EAP program.
3. Written informed consent signed by the patient or legal guardian prior to entering the EAP in accordance with the ICH GCP guidelines. If the written informed consent is provided by the legal guardian because the patient is unable to do so, a written or verbal consent from the patient must also be obtained.
EXCLUSION CRITERIA
1\. Patients that have previously discontinued for any reason from studies YKP3089C013, YKP3089C017 and YKP3089C021.
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT04513860
Study Brief:
Protocol Section:
NCT04513860