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Hepatotoxicity Related to Protein Kinase Inhibitors

NCT05430126 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 600000

Last updated 2022-06-28

No results posted yet for this study

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).

Conditions

Interventions

DRUG

Protein Kinase Inhibitor

This retrospective pharmacovigilance study will include protein kinase inhibitor and exclude those drugs known to cause hepatotoxicities

Sponsors & Collaborators

  • Central South University

    lead OTHER

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-19
Primary Completion
2022-07-20
Completion
2022-08-10
FDA Drug
Yes

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05430126 on ClinicalTrials.gov