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NCT03833297: HePATOX

Monitoring the HePAtological TOXicity of Drugs (HePATOX)

Completed Last updated 5 April 2023
What this trial tests

trial testing Drugs inducing hepatological toxicity in Liver Diseases in 1,000 participants. Completed in 4 April 2023.

Timeline
4 February 2019
Primary endpoint
4 February 2020
4 April 2023

Quick facts

Lead sponsorGroupe Hospitalier Pitie-Salpetriere
StatusCompleted
Study typeOBSERVATIONAL
Enrollment1,000
Start date4 February 2019
Primary completion4 February 2020
Estimated completion4 April 2023
Sites1 location across France

Drugs / interventions tested

Conditions studied

Sponsor

Groupe Hospitalier Pitie-Salpetriere

Who can join

18 and older, any sex, with Liver Diseases or Liver Dysfunction. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Characterization of auto-immune hepatitis associated with the use of anti-TNFα agents: An analysis of 389 cases in VigiBase.
    Vollmer O, Felten R, Mertz P, Lebrun-Vignes B, et al · · 2020 · cited 24× · PMID 31917266 · DOI 10.1016/j.autrev.2020.102460

Verify or expand the search:

Other recruiting trials for Liver Diseases

Currently open trials in the same condition.

Other Groupe Hospitalier Pitie-Salpetriere trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03833297.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing