NCT03947034

Monitoring the Hyperammonaemia:TOXicity of Drugs (AmmoTOX)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 2,700 (actual)
• Sponsor: Groupe Hospitalier Pitie-Salpetriere · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hyperammonemia
• Metabolic Disease
• Adverse Drug Event
• Drug Toxicity

Interventions

Type	Name	Description
DRUG	Drugs inducing hyperammonemia	Drugs susceptible to induce metabolic toxicities such as hyperammonemia

Timeline

• Start date: 2019-05-01
• Primary completion: 2020-05-30
• Completion: 2023-04-04
• First posted: 2019-05-13
• Last updated: 2023-04-05

Locations

1 site across 1 country: France

Regulatory

• FDA-regulated drug study