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 @ 2:32 AM
Ignite Modification Date:
2025-12-25 @ 2:32 AM
NCT ID:
NCT04568434
Eligibility Criteria:
Key Inclusion Criteria:
* A diagnosis of genetically confirmed Familial Chylomicronemia Syndrome (type 1 Hyperlipoproteinemia)
* Fasting TG ≥ 880 mg/dL (10 millimoles per liter (mmol/L) at Screening
* History of pancreatitis. Patients without a documented history of pancreatitis are also eligible but their enrollment will be capped at 35%
* Stable doses of statins, omega-3 fatty acids, fibrates, or other lipid-lowering medications are allowed
Key Exclusion Criteria:
* Acute coronary syndrome within 6 months of Screening
* Major surgery within 3 months of Screening
* Have any other conditions, which, in the opinion of the Investigator would make the participant unsuitable for inclusion, or could interfere with participating in or completing the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04568434
Study Brief:
Protocol Section:
NCT04568434