A Phase 4 interventional study of N-acetylcysteine in Acute Liver Failure and Fulminant Hepatic Failure, sponsored by University of Texas Southwestern Medical Center. Terminated at 21 sites in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2020-06-01.
Sponsored by University of Texas Southwestern Medical Center · Phase 4, Interventional, and Treatment
This proposed study is a multi-center open label study to determine if N-acetylcysteine has any survival benefits in patients with acute liver failure.
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.
445 studies on the registry are indexed under Liver Failure; 69 are open to participants now.
This study's enrollment of 255 is above the median of 43 across 276 interventional studies indexed under Liver Failure.
Browse Liver Failure studies →University of Texas Southwestern Medical Center is the lead sponsor of 990 studies on the registry; 201 are open to participants now.
Of its 135 completed or terminated interventional studies of FDA-regulated products, 100 (74%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Drug: N-acetylcysteine
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.
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
Also known as: Mucomyst
Survival Rate With or Without Transplant
The primary outcome is to compare all patients who survive (with or without transplant) to those who die.
Time frame: 3 Weeks
Survival Rate With or Without Transplant
The primary outcome is to compare all patients who survive (with or without transplant) to those who die.
Time frame: 1-year follow-up
Survival Rate With or Without Transplant
The primary outcome is to compare all patients who survive (with or without transplant) to those who die.
Time frame: 2-year follow-up
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).
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. Data was not collected since study was terminated, therefore no data to analyze.
Time frame: 3 Week follow-up
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).
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. Data was not collected since study was terminated.
Time frame: 1-year follow-up
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).
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. Data was not collected since study was terminated.
Time frame: 2-year follow-up
| Milestone | N-acetycylcysteine |
|---|---|
| Started | 8 |
| Completed | 8 |
| Not completed | 0 |
The primary outcome is to compare all patients who survive (with or without transplant) to those who die.
No measurements were reported for this outcome.
The primary outcome is to compare all patients who survive (with or without transplant) to those who die.
No measurements were reported for this outcome.
The primary outcome is to compare all patients who survive (with or without transplant) to those who die.
No measurements were reported for this outcome.
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. Data was not collected since study was terminated, therefore no data to analyze.
No measurements were reported for this outcome.
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. Data was not collected since study was terminated.
No measurements were reported for this outcome.
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. Data was not collected since study was terminated.
No measurements were reported for this outcome.
Collected over Adverse events were collected during the 72-hour infusion period.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| N-acetycylcysteine | — | 0/8 (0%) | 1/8 (12.5%) |
| Event | N-acetycylcysteine |
|---|---|
| PruritusSkin and subcutaneous tissue disorders | 1/8 |
| Age, Categorical(Participants) | N-acetycylcysteine |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 8 |
| >=65 years | 0 |
| Age, Continuous(years) | N-acetycylcysteine |
|---|---|
| Median | 46 (23 to 67) |
| Sex: Female, Male(Participants) | N-acetycylcysteine |
|---|---|
| Female | 5 |
| Male | 3 |
| Region of Enrollment(participants) | N-acetycylcysteine |
|---|---|
| United States | 8 |
Plan to share: No
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University of Texas Southwestern Medical Center