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

  Show 27 Study Locations
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
Wounds and Injuries
Hepatic Insufficiency
Liver Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on August 28, 2014