Study of N-Acetylcysteine in Acute Liver Failure (ALF) (ONAC)
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|ClinicalTrials.gov Identifier: NCT00896025|
Recruitment Status : Terminated (The low enrollment did not provide statistical power for any meaningful results.)
First Posted : May 11, 2009
Results First Posted : January 29, 2014
Last Update Posted : February 12, 2019
|Condition or disease||Intervention/treatment||Phase|
|Acute Liver Failure Fulminant Hepatic Failure||Drug: N-acetylcysteine||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||255 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Open label-comparator is historical data.|
|Masking:||None (Open Label)|
|Official Title:||A Multi-Center Trial to Study Acute Liver Failure: N-Acetylcysteine (NAC) Open Label Use Study|
|Study Start Date :||December 2008|
|Actual Primary Completion Date :||October 2009|
|Actual Study Completion Date :||December 2010|
Active Comparator: N-acetycylcysteine
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 N-acetylcysteine 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
No Intervention: Standard of care
Each eligible Acute Liver Failure patient for whom the investigator chooses not to utilize N-acetylcysteine may serve as a control and receives standard of care.
- 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 ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00896025
Show 21 Study Locations
|Principal Investigator:||William M Lee, MD||UT Southwestern Medical Center at Dallas|