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NCT Number: NCT03833297

Monitoring the HePAtological TOXicity of Drugs (HePATOX)

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).

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Key information

Conditions

Liver Diseases Digestive System Diseases Hepatic Insufficiency Hepatotoxicity Liver Dysfunction Liver Failure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

AP-HP, Pitié-Salpêtrière Hospital, Department of Pharmacology, CIC-1421, Pharmacovigilance Unit, INSERM

Paris, 75013, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Drugs inducing hepatological toxicity

Drug

Drugs susceptible to induce hepatological toxicities

Primary outcomes

  1. Hepatological toxicities of drugs Identification and report of cases of hepatological toxicities associated with drugs.

    Time frame: Case reported in the World Health Organization (WHO) database of individual safety case reports to 04/02/2019

Secondary outcomes

  1. Causality assessment of reported hepatological toxicities events according to the WHO system

    Time frame: Case reported in the World Health Organization (WHO) database of individual safety case reports to 04/02/2019

  2. Description of the type of hepatoilogical toxicity depending on the category of drug

    Time frame: Case reported in the World Health Organization (WHO) database of individual safety case reports to 04/02/2019

  3. Description of the other immune related adverse events concomitant to the hepatological toxicity induced by drugs

    Time frame: Case reported in the World Health Organization (WHO) database of individual safety case reports to 04/02/2019

  4. Description of the duration of treatment when the toxicity happens (role of cumulative dose)

    Time frame: Case reported in the World Health Organization (WHO) database of individual safety case reports to 04/02/2019

  5. Description of the drug-drug interactions associated with adverse events

    Time frame: Case reported in the World Health Organization (WHO) database of individual safety case reports to 04/02/2019

  6. Description of the pathologies (cancer) for which the incriminated drugs have been prescribed

    Time frame: Case reported in the World Health Organization (WHO) database of individual safety case reports to 04/02/2019

  7. Description of the population of patients having hepatological toxicity adverse event

    Time frame: Case reported in the World Health Organization (WHO) database of individual safety case reports to 04/02/2019

Sponsors and collaborators

Lead sponsor

Groupe Hospitalier Pitie-Salpetriere

Other

Registry information

Official study title

Monitoring the HePAtological TOXicity of Drugs

Acronym: HePATOX

Important dates

Study start
2019
Primary completion
2020
Study completion
2023
First posted
Feb 7, 2019
Registry last updated
Apr 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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