Study of N-Acetylcysteine in Acute Liver Failure (ALF) (ONAC)
This proposed study is a multi-center open label study to determine if N-acetylcysteine has any survival benefits in patients with ALF.
Acute Liver Failure
Fulminant Hepatic Failure
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Multi-Center Trial to Study Acute Liver Failure: N-Acetylcysteine (NAC) Open Label Use Study|
- The Primary Outcome is to Compare All Patients Who Survive (With or Without Transplant) to Those Who Die. [ Time Frame: 3 Weeks, 1-year and 2-year follow-ups ] [ Designated as safety issue: No ]
- To Compare Patients Who Survive Without Transplantation to All Other Patients Enrolled in This Study (Those Who Receive a Transplant and Live, Those Who Receive a Transplant and Die, or Those Who Die Before Transplantation). [ Time Frame: 3 Weeks, 1-year and 2-year follow-ups ] [ Designated as safety issue: No ]
|Study Start Date:||December 2008|
|Study Completion Date:||December 2010|
|Primary Completion Date:||October 2009 (Final data collection date for primary outcome measure)|
Each eligible Acute Liver Failure patient will be given N-acetylcysteine (NAC), beginning at a dose of 150 mg/kg bodyweight in 250 ml 5% dextrose over one hour, followed by 50 mg/kg in 500 ml 5% dextrose over four hours, and 125 mg/kg in 1000 ml 5% dextrose over 19 hours, then 150 mg/kg in 1000 ml 5% dextrose per 24 hours for an additional 48 hours. The patient will be on continuous NAC infusion for a total of 72 hours.
Patients will be included in the trial from the onset of any hepatic coma grade and will receive NAC for the following 72 hrs.
NAC Solutions: The N-acetylcysteine will be added to 5% dextrose in defined concentrations according to the sequence of four specific doses required for the study.
i.Solution A: 150 mg/kg bodyweight in 250 ml 5% dextrose over one hour
ii.Solution B: 50 mg/kg in 500 ml 5% dextrose over four hours
iii.Solution C: 125 mg/kg in 1000 ml 5% dextrose over 19 hours
iv.Solution D: 150 mg/kg in 1000 ml 5% dextrose per 24 hours
v.Solution E: 150 mg/kg in 1000 ml 5% dextrose per 24 hours
Other Name: Mucomyst
Patients admitted to study sites with carefully defined criteria for acute liver failure and who are thought not to have acetaminophen toxicity, mushroom poisoning, pregnancy-related liver failure, or malignancy will be eligible. Each patient will receive intravenously in solution of 5% dextrose in water containing N-acetylcysteine, beginning at a dose of 150 mg/kg bodyweight in 250 ml 5% dextrose over one hour, and in declining doses over a total of 72 hours. Care of patients and consideration of transplantation or other clinical decisions will not be affected by the study or the use of study drug or placebo.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00896025
Show 21 Study Locations
|Principal Investigator:||William M Lee, MD||UT Southwestern Medical Center at Dallas|