Clinical trial NCT03833297: Monitoring the HePAtological TOXicity of Drugs (HePATOX)
Official title: Monitoring the HePAtological TOXicity of Drugs
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Liver Diseases
Liver Dysfunction
Liver Failure
Hepatotoxicity
Keywords: hepatological disease
hepatotoxicity
chemotherapies
drugs
Lead sponsor: Groupe Hospitalier Pitie-Salpetriere
Sponsor class: OTHER
First posted: 2019-02-07
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated with a drug that could be reported in the WHO's pharmacovigilance database

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.

Eligibility criteria: 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

Primary outcomes:
measure: Hepatological toxicities of drugs Identification and report of cases of hepatological toxicities associated with drugs.
timeFrame: Case reported in the World Health Organization (WHO) database of individual safety case reports to 04/02/2019
Secondary outcomes:
measure: Causality assessment of reported hepatological toxicities events according to the WHO system
timeFrame: Case reported in the World Health Organization (WHO) database of individual safety case reports to 04/02/2019
measure: Description of the type of hepatoilogical toxicity depending on the category of drug
timeFrame: Case reported in the World Health Organization (WHO) database of individual safety case reports to 04/02/2019
measure: Description of the other immune related adverse events concomitant to the hepatological toxicity induced by drugs
timeFrame: Case reported in the World Health Organization (WHO) database of individual safety case reports to 04/02/2019
measure: Description of the duration of treatment when the toxicity happens (role of cumulative dose)
timeFrame: Case reported in the World Health Organization (WHO) database of individual safety case reports to 04/02/2019
measure: Description of the drug-drug interactions associated with adverse events
timeFrame: Case reported in the World Health Organization (WHO) database of individual safety case reports to 04/02/2019
measure: Description of the pathologies (cancer) for which the incriminated drugs have been prescribed
timeFrame: Case reported in the World Health Organization (WHO) database of individual safety case reports to 04/02/2019
measure: Description of the population of patients having hepatological toxicity adverse event
timeFrame: Case reported in the World Health Organization (WHO) database of individual safety case reports to 04/02/2019
Other outcomes:
Locations:
city: Paris
country: France
facility: AP-HP, Pitié-Salpêtrière Hospital, Department of Pharmacology, CIC-1421, Pharmacovigilance Unit, INSERM
Study officials:
References: