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 @ 11:08 PM
Ignite Modification Date:
2025-12-24 @ 11:08 PM
NCT ID:
NCT00244569
Eligibility Criteria:
Inclusion Criteria:
* Adult men and women (age 18+)
* Liver histology consistent with NAFLD/NASH performed within the past 24 months
* Patients with cirrhosis must have ultrasound, computed tomography (CT) scan, or magnetic resonance imaging (MRI) examination of liver performed within the previous 6 months demonstrating no evidence for hepatocellular carcinoma
Exclusion Criteria:
* Any liver disease beyond NAFLD/NASH
* Severe congestive heart failure
* Severe pulmonary hypertension
* Chronic renal insufficiency defined by a serum creatinine above normal
* Uncontrolled diabetes mellitus
* Any autoimmune disorder which is currently being treated with immune suppressive medication
* Proven or suspected hepatocellular carcinoma
* Previous surgical bypass surgery for morbid obesity
* Extensive small bowel resection
* Patients currently receiving total parenteral nutrition
* Recipients of any organ transplant
* Women who are pregnant
* Patients who, in the opinion of the investigator, should not be enrolled in this study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00244569
Study Brief:
Protocol Section:
NCT00244569