NCT06670391

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2023

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

October 29, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 1, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2025

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

May 4, 2025

Status Verified

April 1, 2025

Enrollment Period

2 years

First QC Date

October 29, 2024

Last Update Submit

April 30, 2025

Conditions

Liver InjuryLiver Injury, Drug-Induced

Outcome Measures

Primary Outcomes (1)

  • Change in ALT (alanine aminotransferase)

    Absolute change

    on day 10

Secondary Outcomes (4)

  • 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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All hospitalized patients from participating medical centers.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Renji Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200127, China

Location

MeSH Terms

Conditions

Chemical and Drug Induced Liver Injury

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesDrug-Related Side Effects and Adverse ReactionsChemically-Induced DisordersPoisoning

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chairman

Study Record Dates

First Submitted

October 29, 2024

First Posted

November 1, 2024

Study Start

May 1, 2023

Primary Completion

April 30, 2025

Study Completion

December 31, 2025

Last Updated

May 4, 2025

Record last verified: 2025-04

Locations

CN(1)