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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00518440
Recruitment Status : Active, not recruiting
First Posted : August 20, 2007
Last Update Posted : March 9, 2020
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
William Lee, University of Texas Southwestern Medical Center

Study Description
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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
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
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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 : January 1998
Estimated Primary Completion Date : August 31, 2020
Estimated Study Completion Date : August 31, 2020
Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Overall Survival [ Time Frame: 1 Year ]

Biospecimen Retention:   Samples With DNA
Serum, Plasma, Urine, DNA and Tissue if available are collected and stored at the NIDDK Central Repository

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who have acute liver injury or acute liver failure and meet inclusion and exclusion criteria
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)

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00518440


Locations
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United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, California
University of California, San Francisco
San Francisco, California, United States, 94143
United States, Connecticut
Yale Medical School
New Haven, Connecticut, United States, 06520
United States, Illinois
Northwestern University Medical School
Chicago, Illinois, United States, 60611
United States, Kansas
Kansas University Medical Center
Kansas City, Kansas, United States, 66160
United States, Michigan
University of Michigan Medical Center
Ann Arbor, Michigan, United States, 48109
United States, Ohio
The Ohio State University
Columbus, Ohio, United States, 43210
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
United States, Texas
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
United States, Virginia
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
United States, Washington
University of Washington
Seattle, Washington, United States, 98195
Canada, Alberta
University of Alberta
Edmonton, Alberta, Canada
Sponsors and Collaborators
William Lee
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
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Principal Investigator: William M Lee, MD University of Southwestern Medical Center
More Information
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Additional Information:

Publications of Results:

Other Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: William Lee, Professor, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT00518440    
Other Study ID Numbers: STU 062010-126
2U01DK058369 ( U.S. NIH Grant/Contract )
First Posted: August 20, 2007    Key Record Dates
Last Update Posted: March 9, 2020
Last Verified: March 2020
Keywords provided by William Lee, University of Texas Southwestern Medical Center:
Liver disease
Liver injury
Additional relevant MeSH terms:
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Liver Failure
Hepatic Insufficiency
Liver Failure, Acute
Liver Diseases
Digestive System Diseases