Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04142723
Recruitment Status : Recruiting
First Posted : October 29, 2019
Last Update Posted : October 29, 2019
Sponsor:
Collaborators:
ALEH
Hospital Nacional Hipolito
Hospital Goyoneche Arequipa
Hospital Nacional Edgardo Rebagliati Martins
HBCASE
Hospital Regional Honorio Delgado Arequipa Peru
Hospital Nacional Daniel Alcides Carrión - Callao
Instituto de Gastroenterología
Hospital Docente Clinico Quirurgico:Manuel Piti Fajardo
Hospital de Clínicas D. N. Avellaneda
Hospital Padilla. Tucuman
Hospital Pablo Soria. Jujuy
FUNDACIÓN SAYANI
Hospital Italiano Buenos Aires
Rosario
Hospital de Gastroenterología Dr Carlos Bonorino Udaondo
Hospital Austral de Buenos Aires
Francisco Alfonso Solís Galindo
Centro de Investigación en Enfermedades Hepáticas y Gastroenterología
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Hospital General de Mexico
Hospital Eugenio Espejo
Hospital de Especialidades de las FF.AA Quito
Hospital Carlos Andrade Marín
Hospital General San Juan de Dios
Hospital Roosevelt
Hospital San Vicente Fundación Medellín
Clinica Universitaria Colombia
Hospital San Vicente Fundación - Rionegro
Fundacion Cardioinfantil
Hospital Pablo Tobon Uribe. Univ. De Antioquia
Fundação Hospital Adriano Jorge
Hospital do Rocio
Hospital das Clinacas Riberao Preto
Universidade Estadual Paulista (UNESP) - Botucatu/São Paulo
FUNDHACRE- Serviço de Assistência Especializada- Acre
Hospital Getúlio Vargas - Teresina/Piauí
Hospital do Servidor Público Estadual - São Paulo/São Paulo
Hospital Federal de Bonsucesso - Rio de Janeiro/Rio de Janeiro
CHP/ Cl Davila / HCUH
Hospital San Juan de Dios
Hospital Sotero Del Rio
Hospital San Borja-Arriaran
University of Chile
Hospital Clinico Universidad Catolica
Hospital de Concepcion
Hospital Escuela
Information provided by (Responsible Party):
Pontificia Universidad Catolica de Chile

Brief 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

Condition or disease Intervention/treatment
Hepatitis, Alcoholic Biological: blood withdraw

Detailed 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

Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 1000 participants
Observational Model: Case-Crossover
Time Perspective: Prospective
Target Follow-Up Duration: 4 Years
Official Title: Alcoholic Hepatitis in Latin-America: A Prospective and Multicentric Study (AH-LATIN).
Actual Study Start Date : June 20, 2019
Estimated Primary Completion Date : June 20, 2022
Estimated Study Completion Date : June 20, 2022

Resource links provided by the National Library of Medicine



Intervention Details:
  • Biological: blood withdraw
    venous blood sampling


Primary Outcome Measures :
  1. Number of subjects hospitalized with alcoholic hepatitis who die at 30, 60 and 90 days. [ Time Frame: 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.



Secondary Outcome Measures :
  1. Number of subjects hospitalized with alcoholic hepatitis who develop complications (infection, gastrointestinal bleeding, renal failure, etc.) [ Time Frame: 4 years ]
    Inquire about the incidence of infections and prevalence of infections resistant to antibiotics in patients hospitalized for alcoholic hepatitis.

  2. Number of subjects with alcoholic hepatitis who are cataloged as responders by Lille score. [ Time Frame: 4 years ]
    with the data bank researches will be able to track patients through health questionnaires

  3. Mean Model of End-Stage Liver Disease (MELD) score at day 0, 30, 60 and 90. [ Time Frame: 4 years ]
    with the data bank researches will be able to track patients through health questionnaires



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Consumption of more than 3 drinks per day in women and more than 4 drinks per day in men
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04142723


Contacts
Layout table for location contacts
Contact: Juan pablo p arab, MD 56223543845 ext 3845 jparab@gmail.com
Contact: Juan Pablo P Roblero, MD 56223543845 ext 3845 jroblero@gmail.com

Locations
Layout table for location information
Chile
Hospital Clinico Unversidad Catolica de Chile Recruiting
Santiago, Chile
Contact: juan p arab, MD    56223543845 ext 3845    jparab@gmail.com   
Contact: juan p roblero, MD    56223543845 ext 3845    jproblero@gmail.com   
Sponsors and Collaborators
Pontificia Universidad Catolica de Chile
ALEH
Hospital Nacional Hipolito
Hospital Goyoneche Arequipa
Hospital Nacional Edgardo Rebagliati Martins
HBCASE
Hospital Regional Honorio Delgado Arequipa Peru
Hospital Nacional Daniel Alcides Carrión - Callao
Instituto de Gastroenterología
Hospital Docente Clinico Quirurgico:Manuel Piti Fajardo
Hospital de Clínicas D. N. Avellaneda
Hospital Padilla. Tucuman
Hospital Pablo Soria. Jujuy
FUNDACIÓN SAYANI
Hospital Italiano Buenos Aires
Rosario
Hospital de Gastroenterología Dr Carlos Bonorino Udaondo
Hospital Austral de Buenos Aires
Francisco Alfonso Solís Galindo
Centro de Investigación en Enfermedades Hepáticas y Gastroenterología
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Hospital General de Mexico
Hospital Eugenio Espejo
Hospital de Especialidades de las FF.AA Quito
Hospital Carlos Andrade Marín
Hospital General San Juan de Dios
Hospital Roosevelt
Hospital San Vicente Fundación Medellín
Clinica Universitaria Colombia
Hospital San Vicente Fundación - Rionegro
Fundacion Cardioinfantil
Hospital Pablo Tobon Uribe. Univ. De Antioquia
Fundação Hospital Adriano Jorge
Hospital do Rocio
Hospital das Clinacas Riberao Preto
Universidade Estadual Paulista (UNESP) - Botucatu/São Paulo
FUNDHACRE- Serviço de Assistência Especializada- Acre
Hospital Getúlio Vargas - Teresina/Piauí
Hospital do Servidor Público Estadual - São Paulo/São Paulo
Hospital Federal de Bonsucesso - Rio de Janeiro/Rio de Janeiro
CHP/ Cl Davila / HCUH
Hospital San Juan de Dios
Hospital Sotero Del Rio
Hospital San Borja-Arriaran
University of Chile
Hospital Clinico Universidad Catolica
Hospital de Concepcion
Hospital Escuela
Investigators
Layout table for investigator information
Principal Investigator: juan pablo p arab, md Pontificia Universidad Catolica de Chile
Additional Information:
Layout table for additonal information
Responsible Party: Pontificia Universidad Catolica de Chile
ClinicalTrials.gov Identifier: NCT04142723    
Other Study ID Numbers: Alcoholic Hepatitis
First Posted: October 29, 2019    Key Record Dates
Last Update Posted: October 29, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pontificia Universidad Catolica de Chile:
alcoholic, liver disease, cirrhosis
Additional relevant MeSH terms:
Layout table for MeSH terms
Hepatitis A
Hepatitis
Hepatitis, Alcoholic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Liver Diseases, Alcoholic
Alcohol-Induced Disorders
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders