Alcoholic Hepatitis in Latin-America: A Prospective and Multicentric Study (AH-LATIN).

Hepatitis, Alcoholic Clinical Trial

Official title:

Alcoholic Hepatitis in Latin-America: A Prospective and Multicentric Study (AH-LATIN).

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04142723
• Other study ID #: Alcoholic Hepatitis
• Status: Recruiting
• Start date: June 20, 2019
• Est. completion date: June 20, 2022

Study information

• Verified date: October 2019
• Source: Pontificia Universidad Catolica de Chile
• Contact: Juan pablo p arab, MD
• Phone: 56223543845
• Email: jparab[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The primary objective of this study is to determine the prevalence of AH in addition to its clinical characteristics and in-hospital mortality of patients that are hospitalized for AH in different hospitals across Latin American countries This study is carried out in different health centers throughout America, with all the countries belonging to the Latin American Association for the study of liver diseases (ALEH) more Canada and United States This would allow us to better understand the epidemiology of AH in our region and thus implement prevention measures with more solid data. Importantly, this would allow us to optimize therapeutic measures

Description:

This study is sponsored and organized by the "group Latin American of interest special in the study of the disease hepatic Alcohol" (ALEH-GLEHA), belonging to the Latin American Association for the study of the hepatic illnesses (ALEH), which is an association non-profit that has nearly 1,000 members from most of the countries of Latin America.

All patients admitted to the hospital with suspected alcoholic hepatitis will be evaluated to see if they can be included in the study. Patients will be enrolled according with the inclusion and exclusion criteria.

The investigators will take a blood sample to be analyzed as part of the necessary data record, for the study of genes and identification of proteins involved in the development, evolution and prognosis of alcoholic hepatitis.

If the medical doctor had instructed to perform a liver biopsy, voluntarily the investigators will ask to participants donate a small share of the surplus of histological sample To achieve this, it is necessary to generate a data bank of clinical information and biological samples (blood, urine, bile, stools, salivary sample or tissue samples) that allows studying the various factors involved in the development and prognosis of this disease in the countries of the Americas.

The investigators will make a clinical follow-up for a year, consisting of phone calls to complete a questionnaire about participant's health. These calls will be made in month 1, 3, 6 and 12 subsequent to participant's hospital discharge.

The data collected are identified by a code and only the study physicians can correlate the data with the participants and medical history, so the participant's identity will not be shared.

There is no financial compensation associated with the study

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: June 20, 2022
• Est. primary completion date: June 20, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

1. Consumption of more than 3 drinks per day (40 g) in women and more than 4 drinks per day (50-60 g) in men.

2. Excessive alcohol consumption for more than 5 years in a row or interrupted.

3. No more than 60 days of abstinence before the onset of jaundice.

4. Bilirubin levels > 3 mg / dL (> 50 µmol / L), AST> 50 IU / mL, AST / ALT ratio> 1.5.

5. Absence of other causes of hepatic disease.

Exclusion Criteria:

1. Age < 18 years

2. Pregnancy or lactation

3. Alcohol abstinence for more than 60 days before the event that led to hospitalization.

4. Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) levels beyond 400 IU/ml.

5. Presence of drug-induced liver injury (DILI), ischemic hepatitis, biliary duct obstruction, viral hepatitis, autoimmune hepatitis or Wilson's disease.

6. Hepatocellular carcinoma beyond the Milan criteria (ie, a single lesion < 5 cm or no more than 3 lesions, the largest of which measures = 3 cm).

7. Extrahepatic neoplasia with a life expectancy of less than 6 months.

8. History of severe extrahepatic disease (eg, chronic kidney failure requiring hemodialysis, severe heart disease (NYHA class = 3), severe chronic lung disease that confers a survival of less than 6 months.

9. Patients who cannot provide informed consent and that lack a responsible legal substitute.

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis, Alcoholic

Intervention

Biological:
• blood withdraw
venous blood sampling

Locations

Country	Name	City	State
Chile	Hospital Clinico Unversidad Catolica de Chile	Santiago

Sponsors (48)

Lead Sponsor

Collaborator

Pontificia Universidad Catolica de Chile

ALEH, Centro de Investigación en Enfermedades Hepáticas y Gastroenterología, CHP/ Cl Davila / HCUH, Clinica Universitaria Colombia, Francisco Alfonso Solís Galindo, Fundação Hospital Adriano Jorge, Fundacion Cardioinfantil, FUNDACIÓN SAYANI, FUNDHACRE- Serviço de Assistência Especializada- Acre, HBCASE, Hospital Austral de Buenos Aires, Hospital Carlos Andrade Marín, Hospital Clinico Universidad Catolica, Hospital das Clinacas Riberao Preto, Hospital de Clínicas D. N. Avellaneda, Hospital de Concepcion, Hospital de Especialidades de las FF.AA Quito, Hospital de Gastroenterología Dr Carlos Bonorino Udaondo, Hospital do Rocio, Hospital do Servidor Público Estadual - São Paulo/São Paulo, Hospital Docente Clinico Quirurgico:Manuel Piti Fajardo, Hospital Escuela, Hospital Eugenio Espejo, Hospital Federal de Bonsucesso - Rio de Janeiro/Rio de Janeiro, Hospital General de Mexico, Hospital General San Juan de Dios, Hospital Getúlio Vargas - Teresina/Piauí, Hospital Goyoneche Arequipa, Hospital Italiano Buenos Aires, Hospital Nacional Daniel Alcides Carrión - Callao, Hospital Nacional Edgardo Rebagliati Martins, Hospital Nacional Hipolito, Hospital Pablo Soria. Jujuy, Hospital Pablo Tobon Uribe. Univ. De Antioquia, Hospital Padilla. Tucuman, Hospital Regional Honorio Delgado Arequipa Peru, Hospital Roosevelt, Hospital San Borja-Arriaran, Hospital San Juan de Dios, Hospital San Vicente Fundación - Rionegro, Hospital San Vicente Fundación Medellín, Hospital Sotero Del Rio, Instituto de Gastroenterología, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran, Rosario, Universidade Estadual Paulista (UNESP) - Botucatu/São Paulo, University of Chile

Country where clinical trial is conducted

Chile, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of subjects hospitalized with alcoholic hepatitis who die at 30, 60 and 90 days.	To determine the clinical characteristics, complications and in-hospital mortality of patients who are hospitalized for alcoholic hepatitis in different establishments in America.; To achieve this, it is necessary to generate a data bank of clinical information and biological samples (blood, urine, bile, stools, salivary sample or tissue samples) that allows studying the various factors involved in the development and prognosis of this disease in the countries of the Americas. This will help us to know aspects of the highest prevalence and mortality from alcoholic hepatitis in Latin Americans in comparison to other regions of the world and useful information in the prevention and early diagnosis of this disease.	90 days
Secondary	Number of subjects hospitalized with alcoholic hepatitis who develop complications (infection, gastrointestinal bleeding, renal failure, etc.)	Inquire about the incidence of infections and prevalence of infections resistant to antibiotics in patients hospitalized for alcoholic hepatitis.	4 years
Secondary	Number of subjects with alcoholic hepatitis who are cataloged as responders by Lille score.	with the data bank researches will be able to track patients through health questionnaires	4 years
Secondary	Mean Model of End-Stage Liver Disease (MELD) score at day 0, 30, 60 and 90.	with the data bank researches will be able to track patients through health questionnaires	4 years

External Links

•   invitation to participate