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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05883891
Other study ID # 5840
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 1, 2017
Est. completion date November 30, 2022

Study information

Verified date May 2023
Source Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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).


Recruitment information / eligibility

Status Completed
Enrollment 52
Est. completion date November 30, 2022
Est. primary completion date September 30, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: - 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.

Study Design


Intervention

Diagnostic Test:
prothrombin time
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.

Locations

Country Name City State
Italy Agostino Gemelli Polyclinic Rome Roma (provincia)

Sponsors (1)

Lead Sponsor Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary response to steroid treatment response to standard medical treatment assessed with Lille scoremat day 7 seven days
Secondary death death occurring during hospitalization from any cause 28 days
Secondary early liver transplantation early transplantation in case of failure of medical treatment 7 days
Secondary infection occurrence of opportunistic infections following steroid treatment 28 days
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