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 @ 10:08 PM
Ignite Modification Date:
2025-12-24 @ 10:08 PM
NCT ID:
NCT01463735
Eligibility Criteria:
Inclusion Criteria:
* Age \> 18 years old
* Cirrhosis (histology or, if not available, based on clinical, biological and radiological findings)
* Total bilirubin \> 60 µmol/ L
* Anemia defined as hemoglobin \< 120 g/L
* Vitamin E deficiency as defined by plasma levels \< 23 µmol/L
Exclusion Criteria:
* Inability or unwillingness to give written consent
* Parenteral nutrition
* Co-medication with Orlistat, Colestipol, anticoagulants
* Active alcohol consumption as assessed by urine analysis
* Gastro-intestinal bleeding within the past 2 weeks
* Gastric bypass
* Moderate to severe renal failure as defined by creatinine clearance \< 60 ml/min
* Hypothyroidism as defined by TSH \> 6 mU/L
* Diagnosis of cancer upon inclusion in the study
* Any other severe condition affecting interfering with the normal conduct of the study
* Already participating in another clinical study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01463735
Study Brief:
Protocol Section:
NCT01463735