A Multi-Center Trial to Study Acute Liver Failure in Adults (ALFSG)
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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 |
- 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) |
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 |
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)
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00518440
| Contact: William M Lee, MD | 214-645-6111 | william.lee@utsouthwestern.edu |
| 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, San Francisco | Recruiting |
| San Francisco, California, United States, 94143 | |
| Contact: Bilal Hameed, MD 415-476-6160 bilal.Hameed@ucsf.edu | |
| Principal Investigator: Bilal Hameed, MD | |
| United States, Connecticut | |
| Yale Medical School | Recruiting |
| New Haven, Connecticut, United States, 06520 | |
| Contact: Michael Schilsky, MD 203-737-1592 michael.schilsky@yale.edu | |
| Principal Investigator: Michael Schilsky, MD | |
| 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, Michigan | |
| University of Michigan Medical Center | Recruiting |
| Ann Arbor, Michigan, United States, 48109 | |
| Principal Investigator: Robert Fontana, MD | |
| United States, Ohio | |
| The Ohio State University | Recruiting |
| Columbus, Ohio, United States, 43210 | |
| Principal Investigator: Jim Hanje, MD | |
| United States, Pennsylvania | |
| University of Pennsylvania | Recruiting |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Contact: Rajender Reddy, MD 215-662-4276 rajender.reddy@uphs.upenn.edu | |
| Principal Investigator: Rajender Reddy, MD | |
| Principal Investigator: Kimberly Forde, MD | |
| United States, South Carolina | |
| Medical University of South Carolina | Recruiting |
| Charleston, South Carolina, United States, 29425 | |
| Contact: David Koch, MD 843-792-6901 kochd@musc.edu | |
| Principal Investigator: David Koch, MD | |
| United States, Texas | |
| 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 | Recruiting |
| Edmonton, Alberta, Canada | |
| Contact: Constantine Karvellas, MD 780-248-1555 dean.karvellas@ualberta.ca | |
| Principal Investigator: Constantine Karvellas, MD | |
| 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 20, 2015 |
| 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 March 03, 2015