NCT03833297

Monitoring the HePAtological TOXicity of Drugs (HePATOX)

Monitoring the HePAtological TOXicity of Drugs

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,000 (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 hepatological system. This study investigates reports of hepatological toxicities, 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 hepatological system and are responsible of a wide range of hepatological diseases and side effects. 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 rare hepatological side effects imputed to drugs. A causality assessment according to the WHO-UMC (World Health Organization - Uppsala Monitoring Center) is systematically applied.

Conditions

• Liver Diseases
• Liver Dysfunction
• Liver Failure
• Hepatotoxicity

Interventions

Type	Name	Description
DRUG	Drugs inducing hepatological toxicity	Drugs susceptible to induce hepatological toxicities

Timeline

• Start date: 2019-02-04
• Primary completion: 2020-02-04
• Completion: 2023-04-04
• First posted: 2019-02-07
• Last updated: 2023-04-05

Locations

1 site across 1 country: France

Regulatory

• FDA-regulated drug study