NCT05883891

Brief 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. 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2017

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2022

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 22, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 1, 2023

Completed
Last Updated

June 1, 2023

Status Verified

May 1, 2023

Enrollment Period

5.3 years

First QC Date

May 22, 2023

Last Update Submit

May 22, 2023

Conditions

Alcoholic Hepatitis

Keywords

early liver transplantationalcoholcirrhosiscorticosteroid therapyMaddrey's discriminant functionLille scoreprothrombin timeAlcohol Use Disordersteroid response

Outcome Measures

Primary Outcomes (1)

  • response to steroid treatment

    response to standard medical treatment assessed with Lille scoremat day 7

    seven days

Secondary Outcomes (3)

  • death

    28 days

  • early liver transplantation

    7 days

  • infection

    28 days

Study Arms (1)

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.

Diagnostic Test: prothrombin time

Interventions

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.

severe alcoholic hepatitis

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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

You may qualify if:

  • \- 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.

You may not qualify if:

  • acute or chronic viral hepatitis,
  • nonalcoholic steatohepatitis,
  • cocaine use,
  • drug-induced liver injury,
  • fulminant Wilsons disease,
  • hepatocellular carcinoma,
  • portal vein thrombosis,
  • biliary obstruction,
  • severe autoimmune liver disease,
  • neoplasms,
  • severe comorbidities.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Agostino Gemelli Polyclinic

Rome, Roma (provincia), 00168, Italy

Location

MeSH Terms

Conditions

Hepatitis, AlcoholicFibrosisAlcoholism

Interventions

Prothrombin Time

Condition Hierarchy (Ancestors)

HepatitisLiver DiseasesDigestive System DiseasesLiver Diseases, AlcoholicAlcohol-Induced DisordersAlcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersPathologic ProcessesPathological Conditions, Signs and SymptomsMental Disorders

Intervention Hierarchy (Ancestors)

Blood Coagulation TestsHematologic TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative TechniquesBlood Physiological PhenomenaCirculatory and Respiratory Physiological Phenomena

Study Officials

  • Giovanni Addolorato

    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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 22, 2023

First Posted

June 1, 2023

Study Start

June 1, 2017

Primary Completion

September 30, 2022

Study Completion

November 30, 2022

Last Updated

June 1, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)