A Retrospective Study in Patients with Liver Injury After the Use of Novel Antineoplastic Agents

Recruiting

• Conditions: Liver Injury; Liver Injury, Drug-Induced

• Registration Number: NCT06670391
• Lead Sponsor: Drug Induced Liver Disease Study Group

Brief Summary

This is an open-enrollment, retrospective, observational study without interventions. Its primary objective is to understand 1) incidence of liver injury among all the hospitalized patient from participating centers after the administration of immune checkpoint inhibitors or molecularly targeted agents; 2) epidemiologic and clinical characteristics of liver injury, including suspected medications, clinical types, histological characteristics, severity, treatment and outcomes.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-05-01
• Status Verified: 2024-10
• Study First Submitted: 2024-10-29
• Study First Submitted QC: 2024-10-30
• Last Update Submitted: 2024-10-30
• Study First Posted: 2024-11-01
• Last Update Posted: 2024-11-01
• Primary Completion: 2024-12-31
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2000

Inclusion Criteria

• Age ≥ 18 years
• Abnormality of liver biochemistry after the administration of any molecularly targeted agent or immune checkpoint inhibitor

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Exclusion Criteria

• Missing major baseline or clinical data
• Prior liver loco-regional therapy or surgery

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in ALT (alanine aminotransferase)	on day 10	Absolute change

Secondary Outcome Measures

Name	Time	Method
Proportion of patients with normalized liver biochemistry	on day 3, 7, 10, 14, 21, and 30	Count of subjects
Change in liver biochemistry	on day 3, 7, 10, 14, 21, and 30	Absolute change
Time to normalization of liver biochemistry	up to 6 month	Days
Proportion of patients with ≥ 50% reduction in liver biochemistry	on day 3, 7, 10, 14, 21, and 30	Count of subjects

Trial Locations

Locations (1)

Renji Hospital, Shanghai Jiao Tong University School of Medicine; 🇨🇳 Shanghai, Shanghai, China