Methylprednisolone acetate (and lidocaine hydrochloride monohydrate listed in product substances) for Acute alcoholic hepatitis | Severe acute alcoholic hepatitis

Inclusion criteria

• {"criterion_text":"- Males and females\n- Age from 18 to 75 years.\n- Diagnosed with acute alcoholic hepatitis per AASLD guidelines or compatible liver histology\n- Maddret Score >= 32\n- Willingness to participate expressed through written informed consent"}

Exclusion criteria

• {"criterion_text":"- Alternate cause of jaundice\n- Uncontrolled concomitan diseases (HBV, HCV, HIV, TB, DILI, HCC or acute pancreatitis)\n- Multiple organ failure or shock\n- Allergy or intolerance to NAC and/or corticosteroids\n- Hepatocellular carcinoma\n- Pregnancy\n- Life expectancy under 12 months due to comorbid conditions\n- Current treatment with nitroglycerin and/or carmazepine\n- Uncontrolled active infections\n- Acute renal failure with creatinine > 2,5 mg/dL\n- Uncontrolled upper gastrointestinal bleeding"}

Primary endpoints

• {"endpoint_text":"- To assess the efficacy of the use of methylprednisolone + NAC, in terms of 1 month mortality, in patients with Severe Acute Alcoholic Hepatitis","definition_or_measurement_approach":"Measure: 1 month mortality (death at one month)."}

Secondary endpoints

• {"endpoint_text":"- To assess mortality at three months and six months","definition_or_measurement_approach":"Measure: mortality at 3 months and 6 months."}
• {"endpoint_text":"- To assess liver complications, infections and renal failure","definition_or_measurement_approach":"Measure: occurrence of liver complications, infections and renal failure during follow-up (definitions not detailed)."}
• {"endpoint_text":"- To assess the tolerance to NAC","definition_or_measurement_approach":"Measure: assessment of tolerance/adverse events related to N-acetylcysteine (specific measures not detailed)."}
• {"endpoint_text":"- To assess the relationship between the Lille index at day 7 and the response to treatment","definition_or_measurement_approach":"Measure: Lille index at day 7 correlated with treatment response (use of Lille score at day 7 as stratification/analysis metric)."}

Spain

Earliest CTIS Part Ii Submission Date

03-12-2024

Latest Decision Or Authorization Date

15-01-2025

Processing Time Days

43

Number Of Sites

9

Number Of Participants

180

Primary sponsor

Full Name

Asociacion Instituto De Investigacion Sanitaria Bioaraba

Organisation Type

Laboratory/Research/Testing facility

Country Of Registered Address

Spain