Ignite Creation Date:
2024-05-05 @ 12:07 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00248625
Status:
COMPLETED
Last Update Posted:
2016-07-28
First Post:
2005-11-03
Brief Title:
N-acetylcysteine in Non-Acetaminophen Pediatric Acute Liver Failure
Sponsor:
University of Pittsburgh
Organization:
University of Pittsburgh
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2016-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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 inclusionexclusion criteria
Patients enrolled in the PALF study registry were able to enroll in the NAC study providing they met the additional required inclusionexclusion criteria
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U01DK072146 | NIH | None | httpsreporternihgovquickSearchU01DK072146 |