N-acetylcysteine in Non-Acetaminophen Pediatric Acute Liver Failure

Last updated: June 16, 2016
Sponsor: University of Pittsburgh
Overall Status: Completed

Phase

3

Condition

Liver Disease

Liver Disorders

Vomiting

Treatment

N/A

Clinical Study ID

NCT00248625
IRB #: 0608007
U01DK072146
  • Ages < 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Meet entry criteria for and be enrolled in the Pediatric Acute Liver Failureprospective database.

  • Able to be evaluated and initiate treatment within the first 24 hours ofhospitalization

  • Patients transferred from referring hospitals to the study site may be considered forenrollment, provided that no other treatment protocol has begun, and that no liversupport device (BAL, extracorporeal liver assist device, transgenic pig perfusion) hasbeen used or is contemplated.

  • Use of fresh frozen plasma infusions will not disqualify patients from participation.

Exclusion

Exclusion Criteria:

  • older than 18 years of age

  • pregnancy

  • ALF that is secondary to acute acetaminophen toxicity, mushroom poisoning, or a knownmalignancy.

  • Patients who exhibit signs of cerebral herniation, have intractable arterialhypotension, 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 NIHguidelines

Study Design

Total Participants: 184
Study Start date:
January 01, 2000
Estimated Completion Date:
October 31, 2010

Study 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 inclusion/exclusion criteria.

Connect with a study center

  • Hospital for Sick Children

    Toronto, Ontario M5G 1X8
    Canada

    Site Not Available

  • Birmingham Children's Hospital

    Birmingham, B4 6NH
    United Kingdom

    Site Not Available

  • King's College Hospital (London, UK)

    London, SE59RS
    United Kingdom

    Site Not Available

  • University of California, San Francisco

    San Francisco, California 94143
    United States

    Site Not Available

  • University of Colorado, Denver Children's Hospital

    Denver, Colorado 80218
    United States

    Site Not Available

  • Emory University, Children's Healthcare of Atlanta

    Atlanta, Georgia 30322
    United States

    Site Not Available

  • Children's Memorial Hospital

    Chicago, Illinois 60614
    United States

    Site Not Available

  • Riley Children's Hospital

    Indianapolis, Indiana 46202
    United States

    Site Not Available

  • Johns Hopkins University

    Baltimore, Maryland 21287
    United States

    Site Not Available

  • Harvard University, Boston Children's Hospital

    Boston, Massachusetts 02115
    United States

    Site Not Available

  • University of Michigan

    Ann Arbor, Michigan 48109
    United States

    Site Not Available

  • St. Louis Children's Hospital

    St. Louis, Missouri 63110
    United States

    Site Not Available

  • Columbia-Presbyterian

    New York, New York 10032
    United States

    Site Not Available

  • Mount Sinai Hospital

    New York, New York 10029
    United States

    Site Not Available

  • University of Cincinnati, Cincinnati Children's Hospital

    Cincinnati, Ohio 45229
    United States

    Site Not Available

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • Children's Hospital of Pittsburgh of UPMC

    Pittsburgh, Pennsylvania 15224
    United States

    Site Not Available

  • Children's Medical Center of Dallas

    Dallas, Texas 75235
    United States

    Site Not Available

  • Baylor College of Medicine

    Houston, Texas 77030
    United States

    Site Not Available

  • University of Washington

    Seattle, Washington 98105
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.