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

Conditions:Hospital, Gastrointestinal
Therapuetic Areas:Gastroenterology, Other
Age Range:18 - Any
Start Date:January 1998
End Date:August 2020
Contact:William M Lee, MD

Use our guide to learn which trials are right for you!

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.

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

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.

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)
We found this trial at
201 East Huron Street
Chicago, Illinois 60611
Principal Investigator: Daniel Ganger, MD
Chicago, IL
Click here to add this to my saved trials
1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
Principal Investigator: Brendan McGuire, MD
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
Birmingham, AL
Click here to add this to my saved trials
Seattle, Washington 98104
(206) 543-2100
Principal Investigator: Iris Liou, MD
Univ of Washington Founded in 1861 by a private gift of 10 acres in what...
Seattle, WA
Click here to add this to my saved trials
Ann Arbor, Michigan 48109
Principal Investigator: Robert Fontana, MD
Ann Arbor, MI
Click here to add this to my saved trials
171 Ashley Avenue
Charleston, South Carolina 29425
Principal Investigator: David Koch, MD
Phone: 843-792-6901
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
Charleston, SC
Click here to add this to my saved trials
281 W. Lane Ave
Columbus, Ohio 43210
(614) 292-6446
Principal Investigator: Jim Hanje, MD
Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
Columbus, OH
Click here to add this to my saved trials
1801 Inwood Rd
Dallas, Texas 75390
(214) 645-3300
Principal Investigator: William M Lee, MD
University of Texas Southwestern Medical Center UT Southwestern is an academic medical center, world-renowned for...
Dallas, TX
Click here to add this to my saved trials
Edmonton, Alberta T6G 2J2
Principal Investigator: Constantine Karvellas, MD
Phone: 780-248-1555
Click here to add this to my saved trials
Kansas City, Kansas
Principal Investigator: Jody Olson, MD
Kansas City, KS
Click here to add this to my saved trials
New Haven, Connecticut 06520
Principal Investigator: Michael Schilsky, MD
Phone: 203-737-1592
New Haven, CT
Click here to add this to my saved trials
Richmond, Virginia 23298
(804) 828-0100
Principal Investigator: R. Todd Stravitz, MD
Virginia Commonwealth University Since our founding as a medical school in 1838, Virginia Commonwealth University...
Richmond, VA
Click here to add this to my saved trials
San Francisco, California 94143
Principal Investigator: Bilal Hameed, MD
Phone: 415-476-6160
San Francisco, CA
Click here to add this to my saved trials