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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
William Lee, University of Texas Southwestern Medical Center

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Acute Liver Failure
Fulminant Hepatic Failure
Intervention Drug: N-acetylcysteine
Enrollment 255
Recruitment Details  
Pre-assignment Details  
Arm/Group Title N-acetycylcysteine
Hide Arm/Group Description Acute liver failure population
Period Title: Overall Study
Started 8
Completed 8
Not Completed 0
Arm/Group Title N-acetycylcysteine
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 8
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants
<=18 years
0
   0.0%
Between 18 and 65 years
8
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 8 participants
46
(23 to 67)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants
Female
5
  62.5%
Male
3
  37.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 8 participants
8
1.Primary Outcome
Title The Primary Outcome is to Compare All Patients Who Survive (With or Without Transplant) to Those Who Die.
Hide Description [Not Specified]
Time Frame 3 Weeks, 1-year and 2-year follow-ups
Hide Outcome Measure Data
Hide Analysis Population Description
The estimated minimum enrollment for any statistical validity was 100 patients. Due to low enrollment (8 participants) and the likelihood of generating any meaningful study data moving forward, the DSMB recommended the early termination of the study. Zero participants were analyzed because the small sample size would not yield meaningful results
Arm/Group Title N-acetycylcysteine
Hide Arm/Group Description:

Acute liver failure population

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

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title 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).
Hide Description [Not Specified]
Time Frame 3 Weeks, 1-year and 2-year follow-ups
Outcome Measure Data Not Reported
Time Frame Adverse events were collected during the 72-hour infusion period.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title N-acetycylcysteine
Hide Arm/Group Description

Acute liver failure population

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

All-Cause Mortality
N-acetycylcysteine
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
N-acetycylcysteine
Affected / at Risk (%) # Events
Total   0/8 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
N-acetycylcysteine
Affected / at Risk (%) # Events
Total   1/8 (12.50%)    
Skin and subcutaneous tissue disorders   
Pruritus   1/8 (12.50%)  1
Indicates events were collected by systematic assessment
Early termination lead to zero subjects analyzed.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: William M. Lee, MD
Organization: University of Texas Southwestern Medical Center
Phone: 214-645-6111
Responsible Party: William Lee, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT00896025     History of Changes
Other Study ID Numbers: 012009-011
NIDDK U-01 058369
First Submitted: May 8, 2009
First Posted: May 11, 2009
Results First Submitted: December 11, 2013
Results First Posted: January 29, 2014
Last Update Posted: February 12, 2019