Alcoholic HepatitisAH2023NCT05883891
Prothrombin Time Predicts Steroid Response in Severe Alcoholic Hepatitis.
An observational study of Alcoholic Hepatitis, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
Alcoholic hepatitis (AH) is the most severe form of acute alcohol-related liver disease. Maddrey's discriminant function (mDF) >32 defines the severe form of AH, which is associated with a high mortality. Corticosteroid therapy (CS) represents the main medical treatment that may reduce short-term mortality. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Alcoholic Hepatitis
- What is being tested?
- prothrombin time
- How many people
- 52 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jun 2017to 30 Nov 2022
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients admitted to the Internal Medicine and Alcohol Related Diseases Unit of a teaching hospital with a clinical diagnosis of severe alcoholic hepatitis
Who may be able to join
- clinical diagnosis of first episode of severe alcoholic hepatitis with Maddrey's function score of 32 or higher, and the absence of contraindication to CS therapy (non-controlled infections/sepsis, hepatic encephalopathy, recent acute gastrointestinal bleeding, severe kidney dysfunction). The diagnosis of AH was based on the criteria of the National Institute on Alcohol Abuse and Alcoholism (NIAAA)-funded Alcoholic Hepatitis Consortia (Crabb DW, 2016). In particular, were enrolled in the study patients with: heavy alcohol use for >6 months, with an average consumption of more than 3 drinks (∼40 g) per day for women and 4 drinks (∼50-60 g) per day for men and with <30 days of abstinence before the onset of jaundice; AST/ALT ratio > 1.5 with an AST level > 45 IU/L (1.5 times upper limit of normal) and < 400 IU/L; serum bilirubin >3 mg/dL.
Who cannot join
- acute or chronic viral hepatitis,
- nonalcoholic steatohepatitis,
- cocaine use,
- drug-induced liver injury,
- fulminant Wilsons disease,
- hepatocellular carcinoma,
Show all 11Show fewer
- portal vein thrombosis,
- biliary obstruction,
- severe autoimmune liver disease,
- neoplasms,
- severe comorbidities.
Trial locations and contacts
1 site in 1 country.
About this study
Alcoholic hepatitis (AH) is the most severe form of acute alcohol-related liver disease. Maddrey's discriminant function (mDF) >32 defines the severe form of AH, which is associated with a high mortality. Corticosteroid therapy (CS) represents the main medical treatment that may reduce short-term mortality. Lille score at day 7 assesses the therapeutic response to steroid therapy. At present, no parameters able to predict the response to steroid therapy have been highlighted. The mDF depends mainly on prothrombin time (PT). Aim of the present study was to evaluate if the PT value could predict the response to CS in severe AH (sAH).
- Conditions
- Alcoholic Hepatitis
- Being tested
- prothrombin time
- Keywords
- early liver transplantation, alcohol, cirrhosis, corticosteroid therapy, Maddrey's discriminant function, Lille score, prothrombin time, Alcohol Use Disorder, steroid response
- Medical subject headings
- Hepatitis, Alcoholic, Fibrosis, Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prothrombin timeDiagnostic test
Prothrombin time at value at diagnosis was used to assess the presence of a correlation with Lille score at day 7 and therefore wether it could predict response to medical treatment.
| Study group | Role | What they receive |
|---|---|---|
| severe alcoholic hepatitis | Patients admitted with a clinical diagnosis of severe alcoholic hepatitis eligible to corticosteroid treatment. Prothrombin time at diagnosis was registered to evaluate wether it correlated with Lille score at day 7 and therefore response to standard medical treatment. Receives: Diagnostic Test: prothrombin time |
What is being measured
The primary outcome is the main question the study is designed to answer.
response to steroid treatment
response to standard medical treatment assessed with Lille scoremat day 7
Measured: seven days
Secondary outcomes (3)
death
death occurring during hospitalization from any cause
Measured: 28 days
early liver transplantation
early transplantation in case of failure of medical treatment
Measured: 7 days
infection
occurrence of opportunistic infections following steroid treatment
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2023
- Study start1 Jun 2017
- Primary completion30 Sep 2022
- Study completion30 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alcoholic HepatitisStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe 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 only
- Time perspective
- Retrospective
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Giovanni Addolorato, Principal investigator, Internal Medicine and Alcohol Related Disease Unit, Department of Medical and Surgical Sciences, Columbus-Gemelli Hospital, Fondazione Policlinico Universitario A. Gemelli IRCCS, Catholic University of Rome, Rome, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05883891
- Sponsor's protocol ID
- 5840
- Acronym
- AH2023
- Status last verified
- May 2023
- First submitted
- 22 May 2023
- Last updated
- 1 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tarli C, Mannucci S, Vecchione M, Antonelli M, Sestito L, Mancarella FA, Tosoni A, Dionisi T, Maccauro V, Sario GD, Burra P, Germani G, Gasbarrini A, Addolorato G. Prothrombin time predicts steroid response in severe alcohol-related hepatitis. Liver Int. 2024 Mar;44(3):823-830. doi: 10.1111/liv.15835. Epub 2024 Jan 18.
PubMed 38238897
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prothrombin Time Predicts Steroid Response in Severe Alcoholic Hepatitis.
- ClinicalTrials.gov ID
- NCT05883891
- Acronym / sponsor ID
- AH2023 / 5840
- Conditions
- Alcoholic Hepatitis
- Keywords
- early liver transplantation, alcohol, cirrhosis, corticosteroid therapy, Maddrey's discriminant function, Lille score, prothrombin time, Alcohol Use Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 1 Jun 2023 (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.
Alcoholic hepatitis (AH) is the most severe form of acute alcohol-related liver disease. Maddrey's discriminant function (mDF) >32 defines the severe form of AH, which is associated with a high mortality. Corticosteroid therapy (CS) represents the main medical treatment that may reduce short-term mortality. Lille score at day 7 assesses the therapeutic response to steroid therapy. At present, no parameters able to predict the response to steroid therapy have been highlighted. The mDF depends mainly on prothrombin time (PT). Aim of the present study was to evaluate if the PT value could predict the response to CS in severe AH (sAH).
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| severe alcoholic hepatitis | – | Diagnostic Test: prothrombin timePatients admitted with a clinical diagnosis of severe alcoholic hepatitis eligible to corticosteroid treatment. Prothrombin time at diagnosis was registered to evaluate wether it correlated with Lille score at day 7 and therefore response to standard medical treatment. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to the Internal Medicine and Alcohol Related Diseases Unit of a teaching hospital with a clinical diagnosis of severe alcoholic hepatitis
Key inclusion criteria (1 listed)
- clinical diagnosis of first episode of severe alcoholic hepatitis with Maddrey's function score of 32 or higher, and the absence of contraindication to CS therapy (non-controlled infections/sepsis, hepatic encephalopathy, recent acute gastrointestinal bleeding, severe kidney dysfunction). The diagnosis of AH was based on the criteria of the National Institute on Alcohol Abuse and Alcoholism (NIAAA)-funded Alcoholic Hepatitis Consortia (Crabb DW, 2016). In particular, were enrolled in the study patients with: heavy alcohol use for >6 months, with an average consumption of more than 3 drinks (∼40 g) per day for women and 4 drinks (∼50-60 g) per day for men and with <30 days of abstinence before the onset of jaundice; AST/ALT ratio > 1.5 with an AST level > 45 IU/L (1.5 times upper limit of normal) and < 400 IU/L; serum bilirubin >3 mg/dL.
Key exclusion criteria (11 listed)
- acute or chronic viral hepatitis,
- nonalcoholic steatohepatitis,
- cocaine use,
- drug-induced liver injury,
- fulminant Wilsons 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 |
|---|---|---|
| prothrombin timeProthrombin time at value at diagnosis was used to assess the presence of a correlation with Lille score at day 7 and therefore wether it could predict response to medical treatment. | Diagnostic test | severe alcoholic hepatitis |
Primary outcome
response to steroid treatment
Time frame: seven days
response to standard medical treatment assessed with Lille scoremat day 7
3 secondary outcomes
death
Time frame: 28 days
early liver transplantation
Time frame: 7 days
infection
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2023.
- Derived from this study: PubMed 38238897Tarli C, Mannucci S, Vecchione M, Antonelli M, Sestito L, Mancarella FA, Tosoni A, Dionisi T, Maccauro V, Sario GD, Burra P, Germani G, Gasbarrini A, Addolorato G. Prothrombin time predicts steroid response in severe alcohol-related hepatitis. Liver Int. 2024 Mar;44(3):823-830. doi: 10.1111/liv.15835. Epub 2024 Jan 18.
- Individual participant dataSharing planned: No
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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.
Giovanni Addolorato principal investigator
Internal Medicine and Alcohol Related Disease Unit, Department of Medical and Surgical Sciences, Columbus-Gemelli Hospital, Fondazione Policlinico Universitario A. Gemelli IRCCS, Catholic University of Rome, Rome, Italy
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 Alcoholic Hepatitis, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
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 1 inclusion and 11 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: finished, as of the sponsor's last update on 1 Jun 2023. 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 Italy. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
response to steroid treatment (time frame: seven days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05883891, which also lists 1 linked publication.
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 1 Jun 2023.