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

N/AActive Not RecruitingNCT06670391

Drug Induced Liver Disease Study Group2,000 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

2,000

Conditions

Liver Injury Liver Injury, Drug-Induced

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age ≥ 18 years * Abnormality of liver biochemistry after the administration of any molecularly targeted agent or immune checkpoint inhibitor Exclusion Criteria: * Missing major baseline or clinical data * Prior liver loco-regional therapy or surgery

Locations (1)

Renji Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

Outcomes

Primary Outcomes

Change in ALT (alanine aminotransferase)

Absolute change

Time frame: on day 10

Secondary Outcomes

Proportion of patients with normalized liver biochemistry

Count of subjects

Time frame: on day 3, 7, 10, 14, 21, and 30

Change in liver biochemistry

Absolute change

Time frame: on day 3, 7, 10, 14, 21, and 30

Time to normalization of liver biochemistry

Days

Time frame: up to 6 month

Proportion of patients with ≥ 50% reduction in liver biochemistry

Count of subjects

Time frame: on day 3, 7, 10, 14, 21, and 30