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 @ 12:17 AM
Ignite Modification Date:
2025-12-25 @ 12:17 AM
NCT ID:
NCT04873258
Eligibility Criteria:
Inclusion Criteria:
1. Male or female volunteers aged ≥18 to ≤80 years at the date of signing the informed consent.
2. Willingness and ability to provide written, personally signed, and dated informed consent, in accordance with the latest ICH Good Clinical Practice (GCP) Guidelines and applicable regulations.
3. An understanding, ability and willingness to fully comply with project procedures and restrictions.
For PART B only:
1\. With a known history of MASLD as evidenced either of:
1. GP diagnosis on HCF
2. Documented Fibroscan or liver US demonstrating MASLD
Exclusion Criteria:
1. Known alcoholic liver disease, history of cirrhosis of any other cause (metabolic, viral hepatitis or other)
2. Any other significant previous liver pathology (liver malignancy, portal hypertension, infiltrative liver disease)
3. Alcohol consumption \>30 units per week
4. An Implanted cardiac devices
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT04873258
Study Brief:
Protocol Section:
NCT04873258