A Multi-Center Trial to Study Acute Liver Failure in Adults (ALFSG)
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| ClinicalTrials.gov Identifier: NCT00518440 |
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Recruitment Status :
Completed
First Posted : August 20, 2007
Last Update Posted : January 28, 2022
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| Condition or disease |
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| Acute Liver Failure Fulminant Hepatic Failure Acute Liver Injury |
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 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 |
| Actual Primary Completion Date : | September 18, 2019 |
| Actual Study Completion Date : | September 18, 2019 |
- Overall Survival [ Time Frame: 1 Year ]
Biospecimen Retention: Samples With DNA
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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 |
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)
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
| 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 | |
| Principal Investigator: | William M Lee, MD | University of Southwestern Medical Center |
Documents provided by William Lee, University of Texas Southwestern Medical Center:
Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| 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: | January 28, 2022 |
| Last Verified: | January 2022 |
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Liver disease Liver injury |
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Liver Failure Hepatic Insufficiency Liver Failure, Acute Liver Diseases Digestive System Diseases |