Monitoring the HePAtological TOXicity of Drugs (HePATOX)

Sponsor

Groupe Hospitalier Pitie-Salpetriere (Other)

Overall Status

Unknown status

CT.gov ID

NCT03833297

Collaborator

(none)

1,000

Enrollment

Location

Anticipated Duration (Months)

83.4

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Liver Diseases Liver Dysfunction Liver Failure Hepatotoxicity	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 Design

Study Type:

Observational

Anticipated Enrollment :

1000 participants

Observational Model:

Case-Only

Time Perspective:

Cross-Sectional

Official Title:

Monitoring the HePAtological TOXicity of Drugs

Actual Study Start Date :

Feb 4, 2019

Anticipated Primary Completion Date :

Feb 4, 2020

Anticipated Study Completion Date :

Feb 4, 2020

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	AP-HP, Pitié-Salpêtrière Hospital, Department of Pharmacology, CIC-1421, Pharmacovigilance Unit, INSERM	Paris		France	75013

Sponsors and Collaborators

Groupe Hospitalier Pitie-Salpetriere

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Joe Elie Salem, Assistant director, clinical investigation center Paris Est, Groupe Hospitalier Pitie-Salpetriere

ClinicalTrials.gov Identifier:

NCT03833297

Other Study ID Numbers:

CIC1421-19-02

First Posted:

Feb 7, 2019

Last Update Posted:

Sep 4, 2019

Last Verified:

Sep 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Yes

Keywords provided by Joe Elie Salem, Assistant director, clinical investigation center Paris Est, Groupe Hospitalier Pitie-Salpetriere

hepatological disease

hepatotoxicity

chemotherapies

drugs

Additional relevant MeSH terms:

Liver Diseases

Liver Failure

Study Results

No Results Posted as of Sep 4, 2019