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 @ 3:25 AM
Ignite Modification Date:
2025-12-25 @ 3:25 AM
NCT ID:
NCT01342705
Eligibility Criteria:
Inclusion Criteria:
* Age over 18
* Biopsy-proven alcoholic cirrhosis
* No previous HCC (treated or not)
* Excessive alcohol consumption, defined by more than 21 glasses weekly in women and more than 28 glasses weekly in men for at least 10 years, and considered as the main cause for liver cirrhosis
* Signed written informed consent
* Hepatic iron overload assessed by MRI (Iron hepatic concentration ≥ 80 μmol/g)
Exclusion Criteria:
* Subjects deprived of their liberty by judicial or administrative decision
* Pregnant women
* Serious associated short-term life threatening disease (except HIV viral co-infection, or the liver disease itself)
* Impossibility of monitoring, whatever the reason.
* Contraindication of phlebotomy
* Haemoglobin \<13.5 g/dL for men and \<12.5g/dL for women (threshold established by the French Blood Agency)
* Congestive heart failure or coronary heart disease
* Hepatic failure (TP\<60%), renal failure (GFR \<50 ml/min) or respiratory insufficiency (chronic dyspnea)
* Poor venous system
* Complication of cirrhosis at time of inclusion (defined as bleeding related to portal hypertension, encephalopathy or ascites)
* Presence of hepatitis B or hepatitis C co-infection
* Presence of liver focal lesion suggestive of HCC
* Child-Pugh score greater than or equal to 7 (Class B or C) at time of inclusion
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01342705
Study Brief:
Protocol Section:
NCT01342705