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 @ 9:42 PM
Ignite Modification Date:
2025-12-24 @ 9:42 PM
NCT ID:
NCT01801332
Eligibility Criteria:
Inclusion Criteria:
* Acute alcoholic hepatitis proven by a liver biopsy (necessary histological findings : neutrophils infiltration, ballooned hepatocytes and Mallory bodies)
* Presence of a severe disease, defined by a Maddrey score higher than or equal to 32, at screening and in baseline (day 0). Maddrey score = total bilirubin in mg/dl + 4,6 X (Prothrombin time patient in sec - prothrombin time control in sec)
* Age between 18 and 75 years old, extremes included
* Recent jaundice or in recent aggravation (less than 3 months)
* Chronic alcohol consumption (more than 40 g/day)
* Informed consent read, understand and signed by the patient (in case of significant encephalopathy, a family representative can signed in place of the patient)
* Maximal delay between admission and randomization of 14 days.
Exclusion Criteria:
* Other disease compromising 6 months survival of the patient
* Positive HIV or HCV serology, positive HBs Antigen
* Uncontrolled bacterial or fungal infection (infection must be judged controlled for at least 3 days)
* Uncontrolled upper GI bleeding (bleeding must be controlled for at least 5 days)
* Type 1 Hepatorenal syndrome (creatinin upper than 2,5 mg/dl), as defined by Salerno F et al, Gut 2007;56:1310-1318
* History of bariatric surgery
* Pentoxyphilline therapy
* MARS therapy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT01801332
Study Brief:
Protocol Section:
NCT01801332