Monitoring the HePAtological TOXicity of Drugs (HePATOX)
HePATOX
1 other identifier
observational
1,000
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2019
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 4, 2019
CompletedStudy Start
First participant enrolled
February 4, 2019
CompletedFirst Posted
Study publicly available on registry
February 7, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 4, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
April 4, 2023
CompletedApril 5, 2023
April 1, 2023
1 year
February 4, 2019
April 4, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (7)
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
- +2 more secondary outcomes
Study Arms (1)
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
Interventions
Drugs susceptible to induce hepatological toxicities
Eligibility Criteria
Patients treated with a drug that could be reported in the WHO's pharmacovigilance database
You may qualify if:
- Case reported in the WHO's pharmacovigilance database till 04/02/2019
You may not qualify if:
- Chronology not compatible between the drug and the toxicity
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
AP-HP, Pitié-Salpêtrière Hospital, Department of Pharmacology, CIC-1421, Pharmacovigilance Unit, INSERM
Paris, 75013, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant director, clinical investigation center Paris Est
Study Record Dates
First Submitted
February 4, 2019
First Posted
February 7, 2019
Study Start
February 4, 2019
Primary Completion
February 4, 2020
Study Completion
April 4, 2023
Last Updated
April 5, 2023
Record last verified: 2023-04