Completed

ALFSGA Multi-Center Trial to Study Acute Liver Failure in Adults

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What is being collected

Data Collection

Collected from today forward - Prospective
DNA Samples
Who is being recruted

Digestive System Diseases+2

+ Liver Diseases

+ Liver Failure

Over 18 Years
See all eligibility criteria
How is the trial designed

Other

Utilizing specific methods not covered by standard models in order to address unique research questions.
Observational
Study Start: January 1998
See protocol details

Summary

Principal SponsorWilliam Lee
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 1998

Actual date on which the first participant was enrolled.

Although ALF is truly an orphan disease affecting only about 2,000 persons per year, its severity, its frequency among young adults, and its high resource utilization justifies the attention paid to it. In addition, ALF has captured the interest and attention of researchers because of its unique pathogenesis and extreme severity, encouraging us to understand the processes underlying all forms of liver injury, by focusing on this most lethal manifestation. The etiologies associated with ALF have continued to change further over the years with an apparent decline in viral hepatitis, and a remarkable increase in acetaminophen toxicity to its current level of \~44-50% of cases. A further problem in studying ALF is that the number of cases of a specific etiology observed at any one institution are vanishingly small. The earliest goals of the ALF Study then were to more carefully define the etiologies of ALF on a national scale, and to finally allow in-depth study of specific ALF causes such as autoimmune ALF, viral hepatitis and Wilson disease (WD). A second group of patients worthy of study are those with acute liver injury.It would be of value to study patients destined to possibly have ALF earlier in their illness for several reasons: first, we might be able to better predict who will progress to full liver failure; second, the current definition requiring encephalopathy limits the number of patients available for study at any site; finally, therapeutic trials might have greater efficacy if begun at earlier disease stages. Patients who are enrolled are referred to ALFSG clinical sites by gastroenterologist/hepatologist and fellows. Detailed clinical data and bio-specimen (sera, urine, plasma, DNA and tissue if available) are collected. Subjects are followed long-term at 6 months and 12 months. Detailed clinical data and sera are collected.

Official TitleA Multi-Center Trial to Study Acute Liver Failure in Adults
NCT00518440
Principal SponsorWilliam Lee
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

3488 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Other

Some studies use unique or mixed approaches that don't fit standard categories. These may include innovative observational methods or studies tailored to specific research questions.


Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Digestive System DiseasesLiver DiseasesLiver FailureLiver Failure, AcuteHepatic Insufficiency

Criteria

ALF Inclusion Criteria: * Written Informed consent from patient's next of kin * Altered mentation of any degree (encephalopathy) * Evidence of moderately severe coagulopathy (INR ≥ 1.5) * A presumed acute illness onset of less than 26 weeks * The NIH guidelines on the inclusion of women and minorities as subjects in clinical research will be observed ALF Exclusion Criteria: * Cirrhosis patients * Alcohol induced liver failure * Known pre-existing chronic liver disease ALI Inclusion Criteria: Acetaminophen (APAP) etiology: acute illness \< 2 wks * INR ≥ 2.0, ALT ≥ 10X ULN Non-acetaminophen etiology: acute illness \< 26 wks * INR≥ 2.0, ALT≥ 10X ULN, TBili ≥ 3 mg/dl ALI Exclusion Criteria: • Altered mentation of any degree (encephalopathy)

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 12 locations

Suspended

University of Alabama at Birmingham

Birmingham, United StatesOpen University of Alabama at Birmingham in Google Maps
Suspended

University of California, San Francisco

San Francisco, United States
Suspended

Yale Medical School

New Haven, United States
Suspended

Northwestern University Medical School

Chicago, United States
Completed12 Study Centers