Hepatitis, AlcoholicNCT04142723
Alcoholic Hepatitis in Latin-America: A Prospective and Multicentric Study (AH-LATIN).
An observational study of Hepatitis, Alcoholic, run by Pontificia Universidad Catolica de Chile at 1 site in Chile.
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… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Hepatitis, Alcoholic
- What is being tested?
- blood withdraw
- How many people
- 1,000 participants
- Where
- 1 siteChile
- Study dates
- 20 Jun 2019to 20 Jun 2022
- How long will I take part?
- 4 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consumption of more than 3 drinks per day in women and more than 4 drinks per day in men
Who may be able to join
- Consumption of more than 3 drinks per day (40 g) in women and more than 4 drinks per day (50-60 g) in men.
- Excessive alcohol consumption for more than 5 years in a row or interrupted.
- No more than 60 days of abstinence before the onset of jaundice.
- Bilirubin levels > 3 mg / dL (> 50 μmol / L), AST> 50 IU / mL, AST / ALT ratio> 1.5.
- Absence of other causes of hepatic disease.
Who cannot join
- Age < 18 years
- Pregnancy or lactation
- Alcohol abstinence for more than 60 days before the event that led to hospitalization.
- Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) levels beyond 400 IU/ml.
- Presence of drug-induced liver injury (DILI), ischemic hepatitis, biliary duct obstruction, viral hepatitis, autoimmune hepatitis or Wilson's disease.
- 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).
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- Extrahepatic neoplasia with a life expectancy of less than 6 months.
- 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.
- Patients who cannot provide informed consent and that lack a responsible legal substitute.
Trial locations and contacts
1 site in 1 country.
Chile1 site, 1 recruiting
- Recruiting
Hospital Clinico Unversidad Catolica de Chile
Santiago
juan p arab, MD, 56223543845 ext. 3845, jparab@gmail.com
juan p roblero, MD, 56223543845 ext. 3845, jproblero@gmail.com
About this study
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
Read the 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
- Conditions
- Hepatitis, Alcoholic
- Being tested
- blood withdraw
- Keywords
- alcoholic, liver disease, cirrhosis
- Medical subject headings
- Hepatitis, Alcoholic, Liver Diseases, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood withdrawBiological
venous blood sampling
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 90 days
Secondary outcomes (3)
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.
Measured: 4 years
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
Measured: 4 years
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
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2019
- Study start20 Jun 2019
- Primary completion20 Jun 2022 (estimated)
- Study completion20 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis, AlcoholicStudies of the same condition, open and under way.
- More trials run by Pontificia Universidad Catolica de ChileThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 4 Years
Sponsor and investigators
- Lead sponsor
- Pontificia Universidad Catolica de Chile
- Sponsor type
- University, hospital or other
- 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, 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
- Responsible party
- Sponsor
- Investigators
- juan pablo p arab, md, Principal investigator, Pontificia Universidad Catolica de Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04142723
- Sponsor's protocol ID
- Alcoholic Hepatitis
- Status last verified
- Oct 2019
- First submitted
- 2 Oct 2019
- Last updated
- 29 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alcoholic Hepatitis in Latin-America: A Prospective and Multicentric Study (AH-LATIN).
- ClinicalTrials.gov ID
- NCT04142723
- Acronym / sponsor ID
- Alcoholic Hepatitis
- Conditions
- Hepatitis, Alcoholic
- Keywords
- alcoholic, liver disease, cirrhosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Pontificia Universidad Catolica de ChileUniversity, hospital or other
- 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, 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
- Study start
- 20 Jun 2019 (actual)
- Primary completion
- 20 Jun 2022 (estimated)
- Study completion
- 20 Jun 2022 (estimated)
- First posted
- 29 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Target follow-up
- 4 Years
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consumption of more than 3 drinks per day in women and more than 4 drinks per day in men
Key inclusion criteria (5 listed)
- Consumption of more than 3 drinks per day (40 g) in women and more than 4 drinks per day (50-60 g) in men.
- Excessive alcohol consumption for more than 5 years in a row or interrupted.
- No more than 60 days of abstinence before the onset of jaundice.
- Bilirubin levels > 3 mg / dL (> 50 μmol / L), AST> 50 IU / mL, AST / ALT ratio> 1.5.
- Absence of other causes of hepatic disease.
Key exclusion criteria (9 listed)
- Age < 18 years
- Pregnancy or lactation
- Alcohol abstinence for more than 60 days before the event that led to hospitalization.
- Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) levels beyond 400 IU/ml.
- Presence of drug-induced liver injury (DILI), ischemic hepatitis, biliary duct obstruction, viral hepatitis, autoimmune hepatitis or Wilson's disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood withdrawvenous blood sampling | Biological | – |
Primary outcome
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.
3 secondary outcomes
Number of subjects hospitalized with alcoholic hepatitis who develop complications (infection, gastrointestinal bleeding, renal failure, etc.)
Time frame: 4 years
Number of subjects with alcoholic hepatitis who are cataloged as responders by Lille score.
Time frame: 4 years
Mean Model of End-Stage Liver Disease (MELD) score at day 0, 30, 60 and 90.
Time frame: 4 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
juan pablo p arab, md principal investigator
Pontificia Universidad Catolica de Chile
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis, Alcoholic, run by Pontificia Universidad Catolica de Chile at 1 site in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Juan pablo p arab, MD (56223543845 ext. 3845, jparab@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of subjects hospitalized with alcoholic hepatitis who die at 30, 60 and 90 days. (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2019.