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
Results First Received: December 11, 2013  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Acute Liver Failure
Fulminant Hepatic Failure
Intervention: Drug: N-acetylcysteine

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
N-acetycylcysteine Acute liver failure population

Participant Flow:   Overall Study
    N-acetycylcysteine  
STARTED     8  
COMPLETED     8  
NOT COMPLETED     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.

Baseline Measures
    N-acetycylcysteine  
Number of Participants  
[units: participants]
  8  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     8  
>=65 years     0  
Age  
[units: years]
Median ( Full Range )
  46  
  ( 23 to 67 )  
Gender  
[units: participants]
 
Female     5  
Male     3  
Region of Enrollment  
[units: participants]
 
United States     8  



  Outcome Measures

1.  Primary:   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 ]

2.  Secondary:   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 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Early termination lead to zero subjects analyzed.


  More Information
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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
e-mail: william.lee@utsouthwestern.edu


No publications provided


Responsible Party: William Lee, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT00896025     History of Changes
Other Study ID Numbers: 012009-011, NIDDK 058369
Study First Received: May 8, 2009
Results First Received: December 11, 2013
Last Updated: January 29, 2014
Health Authority: United States: Food and Drug Administration