Monitoring the HePAtological TOXicity of Drugs (HePATOX) (HePATOX)

Monitoring the HePAtological TOXicity of Drugs

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).

Study Overview

• Status: Completed
• Conditions: Liver Diseases; Liver Failure; Liver Dysfunction; Hepatotoxicity
• Intervention / Treatment: Drug: Drugs inducing hepatological toxicity

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 Type: Observational
• Enrollment (Actual): 1000

Contacts and Locations

Study Locations

• France
  • Paris, France, 75013
    • AP-HP, Pitié-Salpêtrière Hospital, Department of Pharmacology, CIC-1421, Pharmacovigilance Unit, INSERM

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients treated with a drug that could be reported in the WHO's pharmacovigilance database

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Hepatological toxicity induced by drugs and chemotherapies; 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	Drug: Drugs inducing hepatological toxicity; Drugs susceptible to induce hepatological toxicities

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Groupe Hospitalier Pitie-Salpetriere

Study record dates

Study Major Dates

• Study Start (Actual): February 4, 2019
• Primary Completion (Actual): February 4, 2020
• Study Completion (Actual): April 4, 2023

Study Registration Dates

• First Submitted: February 4, 2019
• First Submitted That Met QC Criteria: February 4, 2019
• First Posted (Actual): February 7, 2019

Study Record Updates

• Last Update Posted (Actual): April 5, 2023
• Last Update Submitted That Met QC Criteria: April 4, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: hepatotoxicity; drugs; chemotherapies; hepatological disease
• Additional Relevant MeSH Terms: Digestive System Diseases; Hepatic Insufficiency; Liver Diseases; Liver Failure
• Other Study ID Numbers: CIC1421-19-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes