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 @ 3:38 AM
Ignite Modification Date:
2025-12-25 @ 3:38 AM
NCT ID:
NCT04347902
Eligibility Criteria:
Inclusion Criteria:
* ≥ 18 years of age,
* chronic intestinal failure on PN including lipids,
* metabolic stability (the absence of pathological laboratory resulting in the change of PN regime for at least one month)
* ability to tolerate up to 1.0 g lipids/kg body weight per day as a part of PN
Exclusion Criteria:
* preexisting liver dysfunction (an elevation of SGOT, SGTP, total bilirubin, GGTP, alkaline phosphatase of more than 3 times x normal value),
* patients with a history of cancer and anti-cancer treatment within the last 5 years,
* severe hyperlipidemia,
* severe coagulopathy,
* severe renal insufficiency,
* acute thromboembolic events,
* positive test for HIV, Hepatitis B or C (from medical history),
* known or suspected drug or alcohol abuse,
* participation in another interventional clinical trial in parallel or within three months prior to the start of this clinical trial,
* for women with childbearing potential (i.e. females who are not chemically or surgically sterile or females who are not postmenopausal) or women of childbearing potential tested positive on standard pregnancy test (urine dipstick) or/and lactation.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT04347902
Study Brief:
Protocol Section:
NCT04347902