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 @ 1:33 AM
Ignite Modification Date:
2025-12-25 @ 1:33 AM
NCT ID:
NCT01756794
Eligibility Criteria:
Inclusion Criteria (Group A):
* Age \> 18 years
* Maddrey score \> 32
* Liver biopsy confirming the diagnosis of alcoholic hepatitis
* Non-response to medical treatment: Lille score ≥ 0.45 at day 7, or early worsening of liver function (MELD score \> 25) despite a low Lille score (\< 0.45)
* Hospitalization stay \< 1 month
* Algorithm score ≥ 220/250.
Inclusion Criteria (Group B):
* Age \>18 years
* Diagnosis of alcoholic cirrhosis
* Alcoholic withdrawal of 6 months minimum before inscription on the transplant list
* MELD score ≥ 15 for patients with hepatocellular carcinoma responding to Milan criteria (1 node \< 5 cm or 3 nodes \< 3 cm)
* MELD score ≥ 20 preferably for patients not displaying hepatocellular carcinoma and that did not obtain an "expert" component
* No recommendation of MELD score for patients having obtained an "expert" component
Non-inclusion Criteria (Group A and B):
* Bacterial or viral infection uncontrolled by medical treatment
* Fungal or aspergillosis uncontrolled infection
* Hepatocellular carcinoma or invasive cancer
* Positive test for HBsAg, Positive test for HIV,Positive PCR for HCV
* Portal thrombosis
* Pregnancy or breast-feeding woman
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01756794
Study Brief:
Protocol Section:
NCT01756794