A Multi-center Study of the Safety and Efficacy of N-acetylcysteine in the Treatment of Acute Liver Failure in Pediatric Patients Not Caused by Acetaminophen.
We have completed patient enrollment in the the double blind, randomized, placebo-controlled trial of intravenous (IV) N-acetylcysteine (NAC) vs. placebo for the treatment of non-acetaminophen ALF. The purpose of this study is to examine the safety and efficacy of intravenous NAC in children with ALF for whom no antidote or other specific treatment is available. Inclusion in the NAC Study required enrollment in the Pediatric Acute Liver Failure (PALF) Study Registry.
Acute Liver Failure
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|Official Title:||A Multi-center Study of the Safety and Efficacy of N-acetylcysteine in the Treatment of Acute Liver Failure in Pediatric Patients Not Caused by Acetaminophen.|
- overall survival rate (spontaneous survival without transplant plus survival following transplantation) at one year following entry into the study. [ Time Frame: One year following entry into the study ] [ Designated as safety issue: Yes ]
- spontaneous recovery (survival without transplant), transplantation, length of hospital stay, number of organ systems failing, infectious complication, highest coma grade of hepatic ENC and the number of days until recovery or death. [ Time Frame: One year following entry into the study ] [ Designated as safety issue: Yes ]
|Study Start Date:||January 2000|
|Study Completion Date:||October 2010|
|Primary Completion Date:||September 2009 (Final data collection date for primary outcome measure)|
The Pediatric Acute Liver Failure (PALF) Study Group to identify, characterize, and develop management strategies for infants, children and adolescents who present with acute liver failure. The PALF study group includes 20 sites (17 in the United States, 2 in the United Kingdom, and 1 in Canada). The primary objective of the Pediatric Acute Liver Failure (PALF) study is to collect, maintain, analyze, and report clinical, epidemiological, and outcome data in children with ALF, including information derived from biospecimens.
Patients enrolled in the PALF study registry were able to enroll in the NAC study providing they met the additional required inclusion/exclusion criteria.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00248625
Show 20 Study Locations
|Principal Investigator:||Robert H Squires, M.D.||Children's Hospital of Pittsburgh, University of Pittsburgh|