NCT06670391
Active, not recruiting
Not Applicable
A Retrospective, Real-world, Electronic Medical Record-based Study on Patients With Liver Injury After the Administration of Novel Antineoplastic Agents
Drug Induced Liver Disease Study Group1 site in 1 country2,000 target enrollmentMay 1, 2023
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Liver Injury
- Sponsor
- Drug Induced Liver Disease Study Group
- Enrollment
- 2000
- Locations
- 1
- Primary Endpoint
- Change in ALT (alanine aminotransferase)
- Status
- Active, not recruiting
- Last Updated
- 12 months ago
Overview
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.
Investigators
Yimin Mao
Chairman
Drug Induced Liver Disease Study Group
Eligibility Criteria
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
Outcomes
Primary Outcomes
Change in ALT (alanine aminotransferase)
Time Frame: on day 10
Absolute change
Secondary Outcomes
- Proportion of patients with normalized liver biochemistry(on day 3, 7, 10, 14, 21, and 30)
- Change in liver biochemistry(on day 3, 7, 10, 14, 21, and 30)
- Time to normalization of liver biochemistry(up to 6 month)
- Proportion of patients with ≥ 50% reduction in liver biochemistry(on day 3, 7, 10, 14, 21, and 30)
Study Sites (1)
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