Ignite Creation Date:
2024-05-06 @ 8:22 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06358196
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-10
First Post:
2024-03-28
Brief Title:
Complex Exploratory Study of Alcohol-Associated Hepatitis
Sponsor:
Pavol Jozef Safarik University
Organization:
Pavol Jozef Safarik University
Study Overview
Official Title:
Complex Exploratory Study of Alcohol-Associated Hepatitis
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CESAH
Brief Summary:
Alcohol-associated hepatitis is a clinical syndrome distinct from steatohepatitis or liver cirrhosis It is associated with high mortality and characterized by an absence of effective treatment while corticosteroids which are currently used as the first-line treatment are effective only in a subpopulation of patients and only on 28-days survival - their effect on survival does not last beyond this interval The proposed study is a complex exploratory study of alcohol-associated hepatitis with several epidemiology- and prognosis-related aims
Detailed Description:
Alcohol-associated hepatitis is a clinical syndrome distinct from steatohepatitis or liver cirrhosis It is associated with high mortality and characterized by an absence of effective treatment while corticosteroids which are currently used as the first-line treatment are effective only in a subpopulation of patients and only on 28-days survival - their effect on survival does not last beyond this interval The proposed study is a complex exploratory study of alcohol-associated hepatitis with the following aims 1 to estimate the standardized annual incidence of severe AH in the Kosice Urban Area 2 to estimate the threshold of alcohol consumption associated with an increased risk of developing AH 3 to compare the diagnostic accuracy of NIAAA vs NIAAAm-CRP against liver biopsy 4 to perform a head-to-head comparison of widely-accepted prognostic models and to develop prognostic models 5 to observe prognosis of nonsevere alcohol-associated hepatitis 6 to observe the evolution of severe alcohol-associated hepatitis 7 to describe the association of hypothalamus-hypopituitary-adrenal axis and Gut-Liver Microbiome Axis and Prognosis of Alcohol-associated Hepatitis 8 to describe the adherence to outpatient psychiatric management and its impact on long-term prognosis 9 to perform a longitudinal evaluation of nutritional status its changes and its impact on long-term prognosis
Study Design This is a multicenter observational study of patients with alcohol-associated hepatitis The total trial duration for each subject is approximately 53 weeks This includes a screening period of a maximum of one week 7 days during which the diagnosis of AH will be confirmed followed by a 52 weeks 365 days observational period
Diagnosis of Alcohol-associated Hepatitis The diagnosis of alcohol-associated hepatitis will be established using the National Institute on Alcohol Abuse and Alcoholism NIAAA diagnostic criteria onset of jaundice within prior 8 weeks ongoing consumption of 40 females or 60 males g alcoholday 6 months with less than 60 days of abstinence before the onset of jaundice aspartate aminotransferase 083µkatL but less than 664 µkatL ASTALT 15 and total serum bilirubin 513 mmolL
NIAAA definitions for AH differentiate between possible AH clinically diagnosed with potential confounding factors in which transjugular liver biopsy is indicated probable AH clinically diagnosed without potential confounding factors and definite AH clinically diagnosed and biopsy proven
Considerations Regarding Patient Admission and Discharge Local standards dictate that patients with acute liver injury or acute liver failure are typically admitted to the 2nd Department of Internal Medicine which specializes in gastroenterology and hepatology This admission is carried out to facilitate further differentiation and provide specific treatment tailored to their condition However patients have the option to decline admission and in such cases will be discharged and managed as outpatients
Once patients provide their consent to participate in the study the screening period will commence This screening phase may have a variable duration and will persist until a definitive diagnosis of AH is confirmed either with or without results from histopathological evaluation of liver specimen
The observational period will begin as soon as the diagnosis of AH will be confirmed with specific treatment in cases of sAH
Patients diagnosed with nAH will undergo evaluation for potential discharge starting on Day 4 of the observational period In contrast patients with sAH will be assessed for their therapeutic response as well as for the possibility of discharge using the Lille score on Day 7 of the observational period If patients do not respond to treatment it will be discontinued
For patients who respond positively to treatment it will be sustained until Day 28 of the observational period Following this period treatment will be gradually tapered down by reducing the dosage by half each week continuing for a total of three weeks
The decision to discharge patients will be based on the absence of significant complications or serious events such as gastrointestinal bleeding overt hepatic encephalopathy infection kidney injury and similar conditions Similarly if any of these events occur after discharge patients will be promptly readmitted and receive appropriate treatment
Patients will be offered psychiatric inpatient or outpatient care before discharge
Study Design This is a multicenter observational study of patients with alcohol-associated hepatitis The total trial duration for each subject is approximately 53 weeks This includes a screening period of a maximum of one week 7 days during which the diagnosis of AH will be confirmed followed by a 52 weeks 365 days observational period
Diagnosis of Alcohol-associated Hepatitis The diagnosis of alcohol-associated hepatitis will be established using the National Institute on Alcohol Abuse and Alcoholism NIAAA diagnostic criteria onset of jaundice within prior 8 weeks ongoing consumption of 40 females or 60 males g alcoholday 6 months with less than 60 days of abstinence before the onset of jaundice aspartate aminotransferase 083µkatL but less than 664 µkatL ASTALT 15 and total serum bilirubin 513 mmolL
NIAAA definitions for AH differentiate between possible AH clinically diagnosed with potential confounding factors in which transjugular liver biopsy is indicated probable AH clinically diagnosed without potential confounding factors and definite AH clinically diagnosed and biopsy proven
Considerations Regarding Patient Admission and Discharge Local standards dictate that patients with acute liver injury or acute liver failure are typically admitted to the 2nd Department of Internal Medicine which specializes in gastroenterology and hepatology This admission is carried out to facilitate further differentiation and provide specific treatment tailored to their condition However patients have the option to decline admission and in such cases will be discharged and managed as outpatients
Once patients provide their consent to participate in the study the screening period will commence This screening phase may have a variable duration and will persist until a definitive diagnosis of AH is confirmed either with or without results from histopathological evaluation of liver specimen
The observational period will begin as soon as the diagnosis of AH will be confirmed with specific treatment in cases of sAH
Patients diagnosed with nAH will undergo evaluation for potential discharge starting on Day 4 of the observational period In contrast patients with sAH will be assessed for their therapeutic response as well as for the possibility of discharge using the Lille score on Day 7 of the observational period If patients do not respond to treatment it will be discontinued
For patients who respond positively to treatment it will be sustained until Day 28 of the observational period Following this period treatment will be gradually tapered down by reducing the dosage by half each week continuing for a total of three weeks
The decision to discharge patients will be based on the absence of significant complications or serious events such as gastrointestinal bleeding overt hepatic encephalopathy infection kidney injury and similar conditions Similarly if any of these events occur after discharge patients will be promptly readmitted and receive appropriate treatment
Patients will be offered psychiatric inpatient or outpatient care before discharge
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None