Ignite Creation Date:
2024-05-05 @ 6:37 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00518440
Status:
COMPLETED
Last Update Posted:
2022-01-28
First Post:
2007-08-17
Brief Title:
A Multi-Center Trial to Study Acute Liver Failure in Adults
Sponsor:
William Lee
Organization:
University of Texas Southwestern Medical Center
Study Overview
Official Title:
A Multi-Center Trial to Study Acute Liver Failure in Adults
Status:
COMPLETED
Status Verified Date:
2022-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ALFSG
Brief 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 encephalopathy
Detailed Description:
Although ALF is truly an orphan disease affecting only about 2000 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 injuryIt 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 gastroenterologisthepatologist 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
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 injuryIt 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 gastroenterologisthepatologist 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2U01DK058369 | NIH | None | httpsreporternihgovquickSearch2U01DK058369 |