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COMPLETEDNCT03947034

Monitoring the Hyperammonaemia:TOXicity of Drugs (AmmoTOX)

Several drugs and chemotherapies seem to have an impact on the metabolic system. This study investigates reports of metabolic toxicities such as hyperammonemia, including the International classificat...

Lead sponsor: Groupe Hospitalier Pitie-Salpetriere•1 locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Groupe Hospitalier Pitie-Salpetriere

Several drugs and chemotherapies seem to have an impact on the metabolic system and are responsible of a wide range of metabolical side effects such as hyperammonemia. Those are poorly described, due to the modification of the pharmacopeia, and the recent recognition of several of these adverse events. This study investigates the main characteristics of patients affected by metabolic side effects imputed to drugs in particular hyperammonemia. A causality assessment according to the WHO-UMC (World Health Organization - Uppsala Monitoring Center) is systematically applied.

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

Inclusion Criteria

•Case reported in the WHO's pharmacovigilance database till 01/05/2019

Exclusion Criteria

•Chronology not compatible between the drug and the toxicity

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: April 5, 2023Terms

Trial snapshot

StatusCOMPLETED

Phase—

Enrollment2,700

Start dateMay 2019

Last updatedApr 5, 2023

Condition

Hyperammonemia Metabolic Disease Adverse Drug Event Drug Toxicity

Locations shown

AP-HP, Pitié-Salpêtrière Hospital, Department of Pharmacology, CIC-1421, Pharmacovigilance Unit, INSERM

Paris

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 5, 2023Data synced to Clareo: July 13, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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