Trial Outcomes & Findings for Study of N-Acetylcysteine in Acute Liver Failure (ALF) (NCT NCT00896025)
NCT ID: NCT00896025
Last Updated: 2020-06-01
Results Overview
The primary outcome is to compare all patients who survive (with or without transplant) to those who die.
TERMINATED
PHASE4
255 participants
3 Weeks
2020-06-01
Participant Flow
Participant milestones
| Measure |
N-acetycylcysteine
Acute liver failure population
|
|---|---|
|
Overall Study
STARTED
|
8
|
|
Overall Study
COMPLETED
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of N-Acetylcysteine in Acute Liver Failure (ALF)
Baseline characteristics by cohort
| Measure |
N-acetycylcysteine
n=8 Participants
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.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
46 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 WeeksPopulation: 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 there was no data to analyze.
The primary outcome is to compare all patients who survive (with or without transplant) to those who die.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 1-year follow-upPopulation: 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.
The primary outcome is to compare all patients who survive (with or without transplant) to those who die.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 2-year follow-upPopulation: 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.
The primary outcome is to compare all patients who survive (with or without transplant) to those who die.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3 Week follow-upPopulation: Data was not collected since study was terminated, therefore there was no data to analyze.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1-year follow-upPopulation: Data was not collected since study was terminated, therefore there was no data to analyze.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2-year follow-upPopulation: Data was not collected since study was terminated, therefore there was no data to analyze.
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.
Outcome measures
Outcome data not reported
Adverse Events
N-acetycylcysteine
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
N-acetycylcysteine
n=8 participants at risk
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
|
|---|---|
|
Skin and subcutaneous tissue disorders
Pruritus
|
12.5%
1/8 • Number of events 1 • Adverse events were collected during the 72-hour infusion period.
|
Additional Information
William M. Lee, MD
University of Texas Southwestern Medical Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place