NCT05430126

Hepatotoxicity Related to Protein Kinase Inhibitors

Hepatotoxicity Related to Protein Kinase Inhibitors in Cancer Patients : an Observational and Retrospective Study Using the FDA Adverse Event Reporting System (FAERS)

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 600,000 (estimated)
• Sponsor: Central South University · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

Although protein kinase inhibitors (PKIs) have proved effective in treating many cancers, few patients receiving PKIs may experience rare but life-threatening hepatotoxicity such as hepatic failure. Today, there is no large-scale retrospective pharmacovigilance study focusing on protein kinase inhibitors-related hepatotoxicity. The objective was to investigate reports of hepatotoxicity related to protein kinase inhibitors using FDA Adverse Event Reporting System (FAERS).

Detailed description

The investigators plan to include FDA approved PKIs from PKIDB, a curated, annotated and updated database of protein kinase inhibitors (https://www.icoa.fr/pkidb/). The search terms of hepatotoxicities will be extracted from "Drug related hepatic disorders-comprehensive search (SMQ)" in MedDRA (Medical Dictionary for Regulatory Activities).

Conditions

• Cancer

Interventions

Type	Name	Description
DRUG	Protein Kinase Inhibitor	This retrospective pharmacovigilance study will include protein kinase inhibitor and exclude those drugs known to cause hepatotoxicities

Timeline

• Start date: 2022-06-19
• Primary completion: 2022-07-20
• Completion: 2022-08-10
• First posted: 2022-06-24
• Last updated: 2022-06-28

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study