N-acetylcysteine in Non-Acetaminophen Pediatric Acute Liver Failure

Completed · Phase 3 · Has a placebo group

Conditions studied: Acute Liver Failure, Hepatic Encephalopathy

In brief

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.

Key facts

Study ID

NCT00248625

Run by

University of Pittsburgh

People needed

184

Starts

2000-01-01

Expected to finish

2010-10-01

Last updated by the study team

2016-07-28

Who can join

Age: any, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Meet entry criteria for and be enrolled in the Pediatric Acute Liver Failure prospective database.
• Able to be evaluated and initiate treatment within the first 24 hours of hospitalization
• Patients transferred from referring hospitals to the study site may be considered for enrollment, provided that no other treatment protocol has begun, and that no liver support device (BAL, extracorporeal liver assist device, transgenic pig perfusion) has been used or is contemplated.
• Use of fresh frozen plasma infusions will not disqualify patients from participation.

You may not qualify if…

• older than 18 years of age
• pregnancy
• ALF that is secondary to acute acetaminophen toxicity, mushroom poisoning, or a known malignancy.
• Patients who exhibit signs of cerebral herniation, have intractable arterial hypotension, require inotropic drugs, or demonstrate signs of sepsis (temperature ≥ 39.5o C or bacteremia) at the time of enrollment
• No exclusion will be made on the basis of race, ethnic group or gender.
• Criteria for inclusion of females and minorities will be those established in the NIH guidelines

Where it is running

• University of California, San Francisco — San Francisco, California, United States
• University of Colorado, Denver Children's Hospital — Denver, Colorado, United States
• Emory University, Children's Healthcare of Atlanta — Atlanta, Georgia, United States
• Children's Memorial Hospital — Chicago, Illinois, United States
• Riley Children's Hospital — Indianapolis, Indiana, United States
• Johns Hopkins University — Baltimore, Maryland, United States
• Harvard University, Boston Children's Hospital — Boston, Massachusetts, United States
• University of Michigan — Ann Arbor, Michigan, United States
• St. Louis Children's Hospital — St Louis, Missouri, United States
• Mount Sinai Hospital — New York, New York, United States
• Columbia-Presbyterian — New York, New York, United States
• University of Cincinnati, Cincinnati Children's Hospital — Cincinnati, Ohio, United States
• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
• Children's Hospital of Pittsburgh of UPMC — Pittsburgh, Pennsylvania, United States
• Children's Medical Center of Dallas — Dallas, Texas, United States
• Baylor College of Medicine — Houston, Texas, United States
• University of Washington — Seattle, Washington, United States
• Hospital for Sick Children — Toronto, Ontario, Canada
• Birmingham Children's Hospital — Birmingham, United Kingdom
• King's College Hospital (London, UK) — London, United Kingdom

Full record on ClinicalTrials.gov

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