Hepatotoxicity Related to Protein Kinase Inhibitors

NCT05430126 | Unknown FDA Drug

• 1 other identifier: CSU20220619
• Study Type: observational
• Target: 600,000
• Locations: 1 country
• Sites: 1

Brief 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

Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Description of the time to onset of hepatotoxicities after PKIs exposure.

  From 2004 to Sep, 2021

• Description of the fatality cases.

  From 2004 to Sep, 2021

Interventions

Protein Kinase Inhibitor DRUG

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Cancer patients treated with protein kinase inhibitors and experiencing hepatotoxicities.

You may qualify if:

• Case reported in the FAERS database of individual safety case reports at the time of the extraction,
• Patients treated with at least 1 PKIs.

You may not qualify if:

• Chronology not compatible between the PKIs and hepatotoxicities

Sponsors & Collaborators

• Central South University: lead

Study Sites (1)

Central South University

Changsha, Hunan, 410000, China

RECRUITING

MeSH Terms

Conditions

Neoplasms

Interventions

Protein Kinase Inhibitors

Intervention Hierarchy (Ancestors)

Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses

Central Study Contacts

Miao Yan, PhD

CONTACT

+8615708460624; yanmiao@csu.edu.cn

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 19, 2022
• First Posted: June 24, 2022
• Study Start: June 19, 2022
• Primary Completion: July 20, 2022
• Study Completion: August 10, 2022
• Last Updated: June 28, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)