Hepatotoxicity Related to Protein Kinase Inhibitors

• Sponsor: Central South University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05430126
• Collaborator: (none)
• Enrollment: 600,000
• Location: 1
• Anticipated Duration (Months): 1.7
• Patients Per Site Per Month: 351201.9

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Cancer	Drug: Protein Kinase Inhibitor

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).

Study Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 600000 participants
• Observational Model: Case-Only
• Time Perspective: Cross-Sectional
• Official Title: Hepatotoxicity Related to Protein Kinase Inhibitors in Cancer Patients : an Observational and Retrospective Study Using the FDA Adverse Event Reporting System (FAERS)
• Actual Study Start Date: Jun 19, 2022
• Anticipated Primary Completion Date: Jul 20, 2022
• Anticipated Study Completion Date: Aug 10, 2022

Outcome Measures

Primary Outcome Measures

1. Hepatotoxicities cases reports related to PKIs (from FAERS database). [From 2004 to Sep, 2021]

   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.

Secondary Outcome Measures

1. Description of the time to onset of hepatotoxicities after PKIs exposure. [From 2004 to Sep, 2021]

   The investigators plan to conduct a time to onset analysis of PKIs-related hepatotoxicities using weibull distribution

2. Description of the fatality cases. [From 2004 to Sep, 2021]

   Fatality cases of PKIs-related hepatotocities will be described.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Central South University	Changsha	Hunan	China	410000

Sponsors and Collaborators

• Central South University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Miao Yan, PhD, Associate Professor, Central South University
• ClinicalTrials.gov Identifier: NCT05430126
• Other Study ID Numbers: CSU20220619
• First Posted: Jun 24, 2022
• Last Update Posted: Jun 28, 2022
• Last Verified: Jun 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Protein Kinase Inhibitors

Study Results

No Results Posted as of Jun 28, 2022