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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by University of Texas Southwestern Medical Center
Sponsor:
Collaborator:
Information provided by (Responsible Party):
William Lee, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT00518440
First received: August 17, 2007
Last updated: February 6, 2014
Last verified: February 2014
  Purpose

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
Acute Liver Failure
Fulminant Hepatic Failure
Acute Liver Injury

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: A Multi-Center Trial to Study Acute Liver Failure in Adults

Further study details as provided by University of Texas Southwestern Medical Center:

Primary Outcome Measures:
  • Overall Survival [ Time Frame: 1 Year ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Serum, Plasma, Urine, DNA and Tissue if available are collected and stored at the NIDDK Central Repository


Estimated Enrollment: 3000
Study Start Date: January 1998
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00518440

Contacts
Contact: William M Lee, MD 214-645-6111 william.lee@utsouthwestern.edu

  Hide Study Locations
Locations
United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35294
Principal Investigator: Brendan McGuire, MD         
United States, California
University of California, Los Angeles Recruiting
Los Angeles, California, United States, 90095
Principal Investigator: Steven Han, MD         
University of California, Davis Recruiting
Sacramento, California, United States, 95817
Principal Investigator: Lorenzo Rossaro, MD         
California Specific Medical Center Terminated
San Francisco, California, United States, 94107
University of California, San Francisco Recruiting
San Francisco, California, United States, 94143
Principal Investigator: Oren Fix, MD         
United States, Connecticut
Yale Medical School Recruiting
New Haven, Connecticut, United States, 06520
Contact: Michael Schilsky, MD         
Sub-Investigator: Michael Schilsky, MD         
Principal Investigator: Sukru Emre, MD         
United States, Florida
Mayo Clinic, Jacksonville Terminated
Jacksonville, Florida, United States, 32216
United States, Georgia
Emory University Recruiting
Atlanta, Georgia, United States, 30322
Principal Investigator: Ram Subramanian, MD         
United States, Illinois
Northwestern University Medical School Recruiting
Chicago, Illinois, United States, 60611
Principal Investigator: Daniel Ganger, MD         
United States, Kansas
Kansas University Medical Center Recruiting
Kansas City, Kansas, United States, 66160
Principal Investigator: Jody Olson, MD         
Sub-Investigator: Ryan Taylor, MD         
United States, Massachusetts
Massachusetts General Hospital Terminated
Boston, Massachusetts, United States, 02114
United States, Michigan
University of Michigan Medical Center Recruiting
Ann Arbor, Michigan, United States, 48109
Principal Investigator: Robert Fontana, MD         
United States, Minnesota
Mayo Clinic, Rochester Terminated
Rochester, Minnesota, United States, 55905
United States, Nebraska
University of Nebraska Terminated
Omaha, Nebraska, United States, 68198
United States, New York
Mount Sinai School of Medicine Terminated
New York, New York, United States, 10029
New York Presbyterian Hospital (Columbia and Cornel) Recruiting
New York, New York, United States, 10032
Principal Investigator: Robert Brown, MD         
United States, Ohio
The Ohio State University Recruiting
Columbus, Ohio, United States, 43210
Principal Investigator: Jim Hanje, MD         
United States, Oregon
Oregon Health Sciences University Terminated
Portland, Oregon, United States, 97239
United States, Pennsylvania
Albert Einstein Medical Center Terminated
Philadelphia, Pennsylvania, United States, 19141
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Principal Investigator: Rajender Reddy, MD         
Principal Investigator: Mical Campbell, MD         
University of Pittsburgh Medical Center Terminated
Pittsburgh, Pennsylvania, United States, 15213
United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Principal Investigator: Adrian Reuben, MBBS         
United States, Texas
Baylor University Medical Center Terminated
Dallas, Texas, United States, 75246
University of Texas Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390
Principal Investigator: William M Lee, MD         
United States, Virginia
Virginia Commonwealth University Recruiting
Richmond, Virginia, United States, 23298
Principal Investigator: R. Todd Stravitz, MD         
United States, Washington
University of Washington Recruiting
Seattle, Washington, United States, 98195
Principal Investigator: Iris Liou, MD         
Canada, Alberta
University of Alberta Not yet recruiting
Edmonton, Alberta, Canada
Principal Investigator: Constantine Karvellas, MD         
Sponsors and Collaborators
William Lee
Investigators
Principal Investigator: William M Lee, MD University of Southwestern Medical Center
  More Information

Additional Information:
Publications:

Additional 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     History of Changes
Other Study ID Numbers: 0697-272, 5 U01 58369
Study First Received: August 17, 2007
Last Updated: February 6, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Texas Southwestern Medical Center:
Liver disease
Liver injury

Additional relevant MeSH terms:
Liver Failure
Liver Failure, Acute
Digestive System Diseases
Hepatic Insufficiency
Liver Diseases

ClinicalTrials.gov processed this record on November 20, 2014