Randomized Study of Acetylcysteine in Patients With Acute Liver Failure Not Caused by Acetaminophen
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|ClinicalTrials.gov Identifier: NCT00004467|
Recruitment Status : Completed
First Posted : October 19, 1999
Last Update Posted : October 13, 2017
I. Determine the safety and efficacy of a short course (72 hours) of intravenous acetylcysteine in patients with acute liver failure for whom no antidote or specific treatment is available.
|Condition or disease||Intervention/treatment||Phase|
|Acute Liver Failure||Drug: N-acetylcysteine (NAC) Drug: Placebo||Phase 3|
Expanded Access : National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.
PROTOCOL OUTLINE: This is a randomized, multicenter study. Patients are randomized to receive intravenous acetylcysteine or placebo for 72 hours. Treatment must begin within 12 hours of hospitalization. Patients who advance to grade III or IV encephalopathy are eligible for liver transplantation.
Patients are followed at 3 weeks.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||173 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Study Start Date :||June 1998|
|Actual Primary Completion Date :||November 2006|
|Actual Study Completion Date :||November 2006|
|Placebo Comparator: Placebo||
Infusion of 5% dextrose
|Experimental: N-acetylcysteine (NAC)||
Drug: N-acetylcysteine (NAC)
Infusion of 5% dextrose with N-acetylcysteine with an initial loading dose of 150 mg/kg/h of NAC over 1 hour, followed by 12.5 mg/kg/h for 4 hours, then continuous infusions of 6.25 mg/kg/h for the remaining 67 hours.
Other Name: Acetadote
- Overall survival rate [ Time Frame: 3 weeks ]
- Survival without liver transplantation (Spontaneous Survival [ Time Frame: 3 weeks ]
- Transplant rate [ Time Frame: 3 weeks ]
- Length of hospital stay [ Time Frame: 3 weeks ]
- Number of organ systems showing failure [ Time Frame: 3 weeks ]
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): NCT00004467
|Study Chair:||William M. Lee, MD||University of Texas Southwestern Medical Center at Dallas, Dallas, TX|