Hepatotoxicity Related to Protein Kinase Inhibitors

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05430126
• Other study ID #: CSU20220619
• Status: Recruiting
• Start date: June 19, 2022
• Est. completion date: August 10, 2022

Study information

• Verified date: June 2022
• Source: Central South University
• Contact: Miao Yan, PhD
• Phone: +8615708460624
• Email: yanmiao[@]csu.edu.cn
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600000
• Est. completion date: August 10, 2022
• Est. primary completion date: July 20, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Case reported in the FAERS database of individual safety case reports at the time of the extraction,

• Patients treated with at least 1 PKIs.

Exclusion Criteria:

• Chronology not compatible between the PKIs and hepatotoxicities

Related Conditions & MeSH terms

• Cancer

Intervention

Drug:
• Protein Kinase Inhibitor
This retrospective pharmacovigilance study will include protein kinase inhibitor and exclude those drugs known to cause hepatotoxicities

Locations

Country	Name	City	State
China	Central South University	Changsha	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
Central South University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hepatotoxicities cases reports related to PKIs (from FAERS database).	The investigators plan to identify number of cases of hepatotoxicities (especially severe toxicities such as hepatic failure) reports related to PKIs reported in the FAERS database by using reporting odds ratios (ROR) and information component (IC), two common method in disproportionality analysis. Clinical features such as gender, age and indications will be displayed, too.	From 2004 to Sep, 2021
Secondary	Description of the time to onset of hepatotoxicities after PKIs exposure.	The investigators plan to conduct a time to onset analysis of PKIs-related hepatotoxicities using weibull distribution	From 2004 to Sep, 2021
Secondary	Description of the fatality cases.	Fatality cases of PKIs-related hepatotocities will be described.	From 2004 to Sep, 2021