Monitoring the HePAtological TOXicity of Drugs (HePATOX)

Liver Diseases Clinical Trial

— HePATOX  

Official title:

Monitoring the HePAtological TOXicity of Drugs

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03833297
• Other study ID #: CIC1421-19-02
• Status: Completed
• Start date: February 4, 2019
• Est. completion date: April 4, 2023

Study information

• Verified date: April 2023
• Source: Groupe Hospitalier Pitie-Salpetriere
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: April 4, 2023
• Est. primary completion date: February 4, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hepatotoxicity
• Liver Diseases
• Liver Dysfunction
• Liver Failure

Intervention

Drug:
• Drugs inducing hepatological toxicity
Drugs susceptible to induce hepatological toxicities

Locations

Country	Name	City	State
France	AP-HP, Pitié-Salpêtrière Hospital, Department of Pharmacology, CIC-1421, Pharmacovigilance Unit, INSERM	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Groupe Hospitalier Pitie-Salpetriere

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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