Study of N-Acetylcysteine in Acute Liver Failure (ALF) (ONAC)

This study has been terminated.
(The low enrollment did not provide statistical power for any meaningful results.)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
William Lee, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT00896025
First received: May 8, 2009
Last updated: January 29, 2014
Last verified: January 2014

May 8, 2009
January 29, 2014
December 2008
October 2009   (final data collection date for primary outcome measure)
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 ]
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: Yes ]
Complete list of historical versions of study NCT00896025 on ClinicalTrials.gov Archive Site
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 ]
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: Yes ]
Not Provided
Not Provided
 
Study of N-Acetylcysteine in Acute Liver Failure (ALF)
A Multi-Center Trial to Study Acute Liver Failure: N-Acetylcysteine (NAC) Open Label Use Study

This proposed study is a multi-center open label study to determine if N-acetylcysteine has any survival benefits in patients with ALF.

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.

Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Acute Liver Failure
  • Fulminant Hepatic Failure
Drug: N-acetylcysteine

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
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 NAC infusion for a total of 72 hours.
Intervention: Drug: N-acetylcysteine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
8
December 2010
October 2009   (final data collection date for primary outcome measure)

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
  • Admitted to study site hospital intensive care units with acute liver failure and who can be evaluated and started on treatment within the first 24 hours of hospitalization
  • All subjects will be between 18 and 70 years
  • The NIH guidelines on the inclusion of women and minorities as subjects will be observed

Exclusion Criteria:

  • Patients less than age 18 or over 70 years of age
  • Acetaminophen or mushroom poisoning induced liver failure
  • Patients with a diagnosis of shock liver (ischemic hepatopathy)
  • Acute liver failure of pregnancy or the HELLP syndrome
  • ALF thought secondary to intrahepatic malignancy
  • Cerebral herniation
  • Intractable arterial hypotension
  • Severe sepsis (temperature >39º C and/or significant bacteremia) present at the time of enrollment
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00896025
012009-011, NIDDK 058369
Yes
William Lee, University of Texas Southwestern Medical Center
William Lee
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Principal Investigator: William M Lee, MD UT Southwestern Medical Center at Dallas
University of Texas Southwestern Medical Center
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP