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Acute Liver FailureALFSGNCT00518440

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

An observational study of Acute Liver Failure and Fulminant Hepatic Failure, run by William Lee at 12 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
How many people
3,488 participants
Where
12 sitesin 2 countries
Study dates
Jan 1998to 18 Sep 2019
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients who have acute liver injury or acute liver failure and meet inclusion and exclusion 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)

Trial locations and contacts

12 sites in 2 countries.

12 sites in 2 countries

United States11 sites

  • University of Michigan Medical Center

    Ann Arbor, Michigan, 48109

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • Northwestern University Medical School

    Chicago, Illinois, 60611

  • The Ohio State University

    Columbus, Ohio, 43210

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390

  • Kansas University Medical Center

    Kansas City, Kansas, 66160

  • Yale Medical School

    New Haven, Connecticut, 06520

  • Virginia Commonwealth University

    Richmond, Virginia, 23298

  • University of California, San Francisco

    San Francisco, California, 94143

  • University of Washington

    Seattle, Washington, 98195

Other trials in United States

Canada1 site

  • University of Alberta

    Edmonton, Alberta

Other trials in Canada

About this study

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.

Read the 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.

Keywords
Liver disease, Liver injury
Medical subject headings
Liver Failure, Acute, Liver Diseases

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival

    Measured: 1 Year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Aug 2007 (estimated)
  2. Study startJan 1998
  3. Primary completion18 Sep 2019
  4. Study completion18 Sep 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
3,488 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00518440
Sponsor's protocol ID
STU 062010-126
Other IDs
2U01DK058369
Acronym
ALFSG
Status last verified
Jan 2022
First submitted
17 Aug 2007
Last updated
28 Jan 2022
Results posted
No
Data monitoring committee
Yes

Publications

  • Vaquero J, Fontana RJ, Larson AM, Bass NM, Davern TJ, Shakil AO, Han S, Harrison ME, Stravitz TR, Munoz S, Brown R, Lee WM, Blei AT. Complications and use of intracranial pressure monitoring in patients with acute liver failure and severe encephalopathy. Liver Transpl. 2005 Dec;11(12):1581-9. doi: 10.1002/lt.20625.

    PubMed 16315300

  • Fontana RJ, Shakil AO, Greenson JK, Boyd I, Lee WM. Acute liver failure due to amoxicillin and amoxicillin/clavulanate. Dig Dis Sci. 2005 Oct;50(10):1785-90. doi: 10.1007/s10620-005-2938-5.

    PubMed 16187174

  • Schiodt FV, Balko J, Schilsky M, Harrison ME, Thornton A, Lee WM; Acute Liver Failure Study Group. Thrombopoietin in acute liver failure. Hepatology. 2003 Mar;37(3):558-61. doi: 10.1053/jhep.2003.50113.

    PubMed 12601353

  • Schiodt FV, Atillasoy E, Shakil AO, Schiff ER, Caldwell C, Kowdley KV, Stribling R, Crippin JS, Flamm S, Somberg KA, Rosen H, McCashland TM, Hay JE, Lee WM. Etiology and outcome for 295 patients with acute liver failure in the United States. Liver Transpl Surg. 1999 Jan;5(1):29-34. doi: 10.1002/lt.500050102.

    PubMed 9873089

  • Metushi IG, Sanders C; Acute Liver Study Group; Lee WM, Uetrecht J. Detection of anti-isoniazid and anti-cytochrome P450 antibodies in patients with isoniazid-induced liver failure. Hepatology. 2014 Mar;59(3):1084-93. doi: 10.1002/hep.26564. Epub 2014 Jan 27.

    PubMed 23775837

  • Karvellas CJ, Cavazos J, Battenhouse H, Durkalski V, Balko J, Sanders C, Lee WM; US Acute Liver Failure Study Group. Effects of antimicrobial prophylaxis and blood stream infections in patients with acute liver failure: a retrospective cohort study. Clin Gastroenterol Hepatol. 2014 Nov;12(11):1942-9.e1. doi: 10.1016/j.cgh.2014.03.011. Epub 2014 Mar 25.

    PubMed 24674942

  • Lee WM. Acetaminophen and the U.S. Acute Liver Failure Study Group: lowering the risks of hepatic failure. Hepatology. 2004 Jul;40(1):6-9. doi: 10.1002/hep.20293.

    PubMed 15239078

  • Vaquero J, Jordano Q, Lee WM, Blei AT; US Acute Liver Failure Study Group. Serum protein S-100b in acute liver failure: Results of the US Acute Liver Failure Study group. Liver Transpl. 2003 Aug;9(8):887-8. doi: 10.1053/jlts.2003.50172. No abstract available.

    PubMed 12884207

  • The acute liver failure study group. Hepatology. 2002 Dec;36(6):1326. doi: 10.1002/hep.510360603. No abstract available.

    PubMed 12447853

  • Murphy EJ, Davern TJ, Shakil AO, Shick L, Masharani U, Chow H, Freise C, Lee WM, Bass NM. Troglitazone-induced fulminant hepatic failure. Acute Liver Failure Study Group. Dig Dis Sci. 2000 Mar;45(3):549-53. doi: 10.1023/a:1005405526283.

    PubMed 10749332

  • Fontana RJ, McCashland TM, Benner KG, Appelman HD, Gunartanam NT, Wisecarver JL, Rabkin JM, Lee WM. Acute liver failure associated with prolonged use of bromfenac leading to liver transplantation. The Acute Liver Failure Study Group. Liver Transpl Surg. 1999 Nov;5(6):480-4. doi: 10.1002/lt.500050607.

    PubMed 10545534

  • Leung PS, Rossaro L, Davis PA, Park O, Tanaka A, Kikuchi K, Miyakawa H, Norman GL, Lee W, Gershwin ME; Acute Liver Failure Study Group. Antimitochondrial antibodies in acute liver failure: implications for primary biliary cirrhosis. Hepatology. 2007 Nov;46(5):1436-42. doi: 10.1002/hep.21828.

    PubMed 17657817

  • Moller HJ, Gronbaek H, Schiodt FV, Holland-Fischer P, Schilsky M, Munoz S, Hassanein T, Lee WM; U.S. Acute Liver Failure Study Group. Soluble CD163 from activated macrophages predicts mortality in acute liver failure. J Hepatol. 2007 Nov;47(5):671-6. doi: 10.1016/j.jhep.2007.05.014. Epub 2007 Jun 21.

    PubMed 17629586

  • Schiodt FV, Ostapowicz G, Murray N, Satyanarana R, Zaman A, Munoz S, Lee WM. Alpha-fetoprotein and prognosis in acute liver failure. Liver Transpl. 2006 Dec;12(12):1776-81. doi: 10.1002/lt.20886.

    PubMed 17133565

  • Rutherford A, Davern T, Hay JE, Murray NG, Hassanein T, Lee WM, Chung RT; Acute Liver Failure Study Group. Influence of high body mass index on outcome in acute liver failure. Clin Gastroenterol Hepatol. 2006 Dec;4(12):1544-9. doi: 10.1016/j.cgh.2006.07.014. Epub 2006 Sep 25.

    PubMed 16996806

Questions about this trial

What is this clinical trial studying?

An observational study of Acute Liver Failure and Fulminant Hepatic Failure, run by William Lee at 12 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (time frame: 1 Year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00518440, which also lists 94 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2022.

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