ALFSG: A Multi-Center Trial to Study Acute Liver Failure in Adults

Sponsor

William Lee (Other)

Overall Status

Completed

CT.gov ID

NCT00518440

Collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (NIH)

3,488

Enrollment

Locations

260.5

Duration (Months)

290.7

Patients Per Site

1.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to collect clinical and epidemiological data as well as serum, plasma, urine, tissue and DNA samples on individuals who have acute liver failure and on individuals who have acute liver injury, a less severe group of patients who have coagulopathy but do not reach the threshold of encephalopathy.

Condition or Disease	Intervention/Treatment	Phase
Acute Liver Failure Fulminant Hepatic Failure Acute Liver Injury

Detailed Description

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.

Study Design

Study Type:

Observational

Actual Enrollment :

3488 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Jan 1, 1998

Actual Primary Completion Date :

Sep 18, 2019

Actual Study Completion Date :

Sep 18, 2019

Outcome Measures

Primary Outcome Measures

Overall Survival [1 Year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama at Birmingham	Birmingham	Alabama	United States	35294
2	University of California, San Francisco	San Francisco	California	United States	94143
3	Yale Medical School	New Haven	Connecticut	United States	06520
4	Northwestern University Medical School	Chicago	Illinois	United States	60611
5	Kansas University Medical Center	Kansas City	Kansas	United States	66160
6	University of Michigan Medical Center	Ann Arbor	Michigan	United States	48109
7	The Ohio State University	Columbus	Ohio	United States	43210
8	Medical University of South Carolina	Charleston	South Carolina	United States	29425
9	University of Texas Southwestern Medical Center	Dallas	Texas	United States	75390
10	Virginia Commonwealth University	Richmond	Virginia	United States	23298
11	University of Washington	Seattle	Washington	United States	98195
12	University of Alberta	Edmonton	Alberta	Canada