ACUTE AND CHRONIC ACETAMINOPHEN OVERDOSE IN PEDIATRIC POPULATION: PROSPECTIVE STUDY OF COHORT TO EVALUATE CLINIC FACTORS AND BIOMARKERS TO PREDICT DEVELOPMENT OF HEPATOTOXICITY/SOBREDOSIS AGUDA Y CRÓNICA DE PARACETAMOL EN POBLACIÓN PEDIÁTRICA: ESTUDIO PROSPECTIVO DE COHORTES PARA EVALUAR LOS FACTORES CLINICOS Y BIOMARCADORES PREDICTORES DE HEPATOTOXICIDAD (GEIPA-2012-01)

Study identification

• EU PAS number:
  EUPAS3276
• Study ID:
  49518
• Official title and acronym:
  ACUTE AND CHRONIC ACETAMINOPHEN OVERDOSE IN PEDIATRIC POPULATION: PROSPECTIVE STUDY OF COHORT TO EVALUATE CLINIC FACTORS AND BIOMARKERS TO PREDICT DEVELOPMENT OF HEPATOTOXICITY/SOBREDOSIS AGUDA Y CRÓNICA DE PARACETAMOL EN POBLACIÓN PEDIÁTRICA: ESTUDIO PROSPECTIVO DE COHORTES PARA EVALUAR LOS FACTORES CLINICOS Y BIOMARCADORES PREDICTORES DE HEPATOTOXICIDAD (GEIPA-2012-01)
• DARWIN EU® study:
  No
• Study countries:
  Spain
• Study description:
  Acetaminophen is the main drug causing acute liver failure in some countries like the United States, UK and other European countries. Acetaminophen hepatotoxicity generally does not appear until several hours and even days after intake, which makes the detection of liver damage often delayed. One reason is that there is not available a biomarker of liver damage efficient to detect liver damage in early stages. The development of acetaminophen toxicity biomarkers could have important clinical implications for groups of patients who can not apply the Rumack-Matthew nomogram, e.g. arrive to the hospital at a late stage (> 24 hours after ingestion), chronic ingestion of acetaminophen, acute ingestion in alcoholic patients, concomitant intake of other drugs which could change the kinetics of acetaminophen and intake of sustained release of acetaminophen. The identification of new biomarkers that are specific to acetaminophen intoxication could be useful in the evaluation of children with acute liver failure of unknown etiology, in addition to predict the occurrence of liver damage in its early stage. Objectives of this study are 1.-To determine the clinical factors and biomarkers (pharmacokinetic, genetic and metabonomics) that predict the development of hepatotoxicity in paediatric population following acute and chronic intake of acetaminophen and 2.- Develop a predictive model to assess the risk of hepatotoxicity in acute and chronic intoxication by acetaminophen suited to paediatric patients for use in clinical practice.
• Study status:
  Planned

Research institutions and networks

Institutions

Hospital La Paz

School of Medicine

Hospital Universitario 12 de Octubre

Spain

Hospital Universitario "La Paz" Madrid, Spain, Hospital Universitario "Gregorio Marañón" Madrid, Spain, Hospital Universitario "Niño Jesús" Madrid, Spain, Hospital Universitario "12 de Octubre" Madrid, Spain

Study timelines

Date when funding contract was signed

Planned: 15/01/2013

Study start date

Planned: 30/01/2013

Data analysis start date

Planned: 01/06/2018

Date of final study report

Planned: 30/09/2022

Sources of funding

Other

More details on funding

Clinical Pharmacology Department, HULP, UAM

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable