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OpenTrials
Active, Not Recruiting

NCT Number: NCT06670391

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Liver Injury Chemical and Drug Induced Liver Injury Chemically-Induced Disorders Digestive System Diseases Drug-Related Side Effects and Adverse Reactions Liver Diseases Liver Injury, Drug-Induced Poisoning

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Renji Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200127, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Change in ALT (alanine aminotransferase)

    Time frame: on day 10

    Absolute change

Secondary outcomes

  1. Proportion of patients with normalized liver biochemistry

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

    Count of subjects

  2. Change in liver biochemistry

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

    Absolute change

  3. Time to normalization of liver biochemistry

    Time frame: up to 6 month

    Days

  4. Proportion of patients with ≥ 50% reduction in liver biochemistry

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

    Count of subjects

Sponsors and collaborators

Lead sponsor

Drug Induced Liver Disease Study Group

Other

Registry information

Official study title

A Retrospective, Real-world, Electronic Medical Record-based Study on Patients With Liver Injury After the Administration of Novel Antineoplastic Agents

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Nov 1, 2024
Registry last updated
May 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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