Monitoring the Hyperammonaemia:TOXicity of Drugs (AmmoTOX)

Completed

• Conditions: Hyperammonemia; Metabolic Disease; Drug Toxicity; Adverse Drug Event
• Interventions: Drug: Drugs inducing hyperammonemia

• Registration Number: NCT03947034
• Lead Sponsor: Groupe Hospitalier Pitie-Salpetriere

Brief Summary

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 classification of disease ICD-10 for treatments in the World Health Organization (WHO) global Individual Case Safety Report (ICSR) database (VigiBase).

Detailed Description

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.

Study Timeline

• Study Start: 2019-05-01
• Study First Submitted: 2019-05-09
• Study First Submitted QC: 2019-05-09
• Study First Posted: 2019-05-13
• Primary Completion: 2020-05-30
• Status Verified: 2023-04
• Study Completion: 2023-04-04
• Last Update Submitted: 2023-04-04
• Last Update Posted: 2023-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2700

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Metabolic toxicity induced by drugs and chemotherapies	Drugs inducing hyperammonemia	Case reported in the World Health Organization (WHO) of metabolic toxicities(such as hyperammonemia) of patient treated by a drug, with a chronology compatible with the drug toxicity

Primary Outcome Measures

Name	Time	Method
Metabolic toxicities (such as hyperammnemia) of drugs Identification and report of cases of metabolic toxicities associated with drugs.	to 01/05/2019	Case reported in the World Health Organization (WHO) database of individual safety case reports

Secondary Outcome Measures

Name	Time	Method
Description of the population of patients having hematological toxicity adverse event	to 01/05/2019	Case reported in the World Health Organization (WHO) database of individual safety case reports
Causality assessment of reported metabolic toxicities events according to the WHO system	to 01/05/2019	Case reported in the World Health Organization (WHO) database of individual safety case reports
Description of the duration of treatment when the toxicity happens (role of cumulative dose)	to 01/05/2019	Case reported in the World Health Organization (WHO) database of individual safety case reports
Description of the drug-drug interactions associated with adverse events	to 01/05/2019	Case reported in the World Health Organization (WHO) database of individual safety case reports
Description of the type of metabolic toxicity depending on the category of drug	to 01/05/2019	Case reported in the World Health Organization (WHO) database of individual safety case reports
Description of the other immune related adverse events concomitant to the metabolic toxicity induced by drugs	to 01/05/2019	Case reported in the World Health Organization (WHO) database of individual safety case reports
Description of the pathologies (cancer) for which the incriminated drugs have been prescribed	to 01/05/2019	Case reported in the World Health Organization (WHO) database of individual safety case reports

Trial Locations

Locations (1)

AP-HP, Pitié-Salpêtrière Hospital, Department of Pharmacology, CIC-1421, Pharmacovigilance Unit, INSERM; 🇫🇷 Paris, France