Monitoring the HePAtological TOXicity of Drugs (HePATOX)

Completed

• Conditions: Liver Dysfunction; Liver Diseases; Liver Failure; Hepatotoxicity
• Interventions: Drug: Drugs inducing hepatological toxicity

• Registration Number: NCT03833297
• Lead Sponsor: Groupe Hospitalier Pitie-Salpetriere

Brief 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.

Study Timeline

• Study Start: 2019-02-04
• Study First Submitted: 2019-02-04
• Study First Submitted QC: 2019-02-04
• Study First Posted: 2019-02-07
• Primary Completion: 2020-02-04
• 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: 1000

Inclusion Criteria

• Case reported in the WHO's pharmacovigilance database till 04/02/2019

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
Hepatological toxicity induced by drugs and chemotherapies	Drugs inducing hepatological toxicity	Case reported in the World Health Organization (WHO) of hepatological toxicities of patient treated by a drug, with a chronology compatible with the drug toxicity

Primary Outcome Measures

Name	Time	Method
Hepatological toxicities of drugs Identification and report of cases of hepatological toxicities associated with drugs.	Case reported in the World Health Organization (WHO) database of individual safety case reports to 04/02/2019

Secondary Outcome Measures

Name	Time	Method
Causality assessment of reported hepatological toxicities events according to the WHO system	Case reported in the World Health Organization (WHO) database of individual safety case reports to 04/02/2019
Description of the type of hepatoilogical toxicity depending on the category of drug	Case reported in the World Health Organization (WHO) database of individual safety case reports to 04/02/2019
Description of the other immune related adverse events concomitant to the hepatological toxicity induced by drugs	Case reported in the World Health Organization (WHO) database of individual safety case reports to 04/02/2019
Description of the duration of treatment when the toxicity happens (role of cumulative dose)	Case reported in the World Health Organization (WHO) database of individual safety case reports to 04/02/2019
Description of the drug-drug interactions associated with adverse events	Case reported in the World Health Organization (WHO) database of individual safety case reports to 04/02/2019
Description of the pathologies (cancer) for which the incriminated drugs have been prescribed	Case reported in the World Health Organization (WHO) database of individual safety case reports to 04/02/2019
Description of the population of patients having hepatological toxicity adverse event	Case reported in the World Health Organization (WHO) database of individual safety case reports to 04/02/2019

Trial Locations

Locations (1)

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