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 @ 2:06 PM
Ignite Modification Date:
2025-12-24 @ 2:06 PM
NCT ID:
NCT02271295
Eligibility Criteria:
Inclusion Criteria:
* Age ≥18 and ≤75 years old
* A diagnosis of cirrhosis based on liver biopsy or on the combination of clinical, laboratory and imaging criteria
* Compensated Child-Pugh B7-C10
* Any of the following causal factors : past but controlled excessive alcohol intake (\<30g/d for men and \<20g/d for women), HCV infection without viral replication, HBV infection without viral replication on therapy, metabolic syndrome, biliary cirrhosis, auto-immune cirrhosis, hemochromatosis, cryptogenetic cirrhosis
Exclusion Criteria:
* Ascites, portal hypertensive bleeding or encephalopathy within the last 3 months prior to enrolment
* Hepatocellular carcinoma non considered in remission
* Budd Chiari syndrome non considered in remission
* Liver transplantation
* F2 or F3 varices without treatment in accordance with recommended guidelines (B-blockers, ligation or both)
* Portal vein thrombosis
* Transjugular intrahepatic portosystemic shunt
* Known extra-hepatic malignancies
* PT\<35%
* Platelet count\<50,000/mm3
* Haemoglobin level \< 9g/dl
* Serum Albumin \< 20g/L
* A bone mineral density T score of less than -4.0 at the lumbar spine or total hip
* Known HIV infection
* Ongoing anticoagulation or antiaggregation
* Renal insufficiency defined by creatinine clearance\<60ml/mn
* Conditions at risk for spontaneous bleeding (except for portal hypertension) or hemostatic abnormalities not related to cirrhosis
* Pregnancy or breast-feeding
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT02271295
Study Brief:
Protocol Section:
NCT02271295