Liver InjuryNCT06670391
A Retrospective Study in Patients With Liver Injury After the Use of Novel Antineoplastic Agents
An observational study of Liver Injury and Liver Injury, Drug-Induced, run by Drug Induced Liver Disease Study Group at 1 site in China.
Trial 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)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Injury, Liver Injury, Drug-Induced
- How many people
- 2,000 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2023to 31 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All hospitalized patients from participating medical centers.
Who may be able to join
- Age ≥ 18 years
- Abnormality of liver biochemistry after the administration of any molecularly targeted agent or immune checkpoint inhibitor
Who cannot join
- Missing major baseline or clinical data
- Prior liver loco-regional therapy or surgery
Trial locations and contacts
1 site in 1 country.
China1 site
Renji Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200127
About this study
Official title: A Retrospective, Real-world, Electronic Medical Record-based Study on Patients With Liver Injury After the Administration 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.
- Conditions
- Liver Injury, Liver Injury, Drug-Induced
- Medical subject headings
- Chemical and Drug Induced Liver Injury
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in ALT (alanine aminotransferase)
Absolute change
Measured: on day 10
Secondary outcomes (4)
Proportion of patients with normalized liver biochemistry
Count of subjects
Measured: on day 3, 7, 10, 14, 21, and 30
Change in liver biochemistry
Absolute change
Measured: on day 3, 7, 10, 14, 21, and 30
Time to normalization of liver biochemistry
Days
Measured: up to 6 month
Proportion of patients with ≥ 50% reduction in liver biochemistry
Count of subjects
Measured: on day 3, 7, 10, 14, 21, and 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2024
- Study start1 May 2023
- Primary completion30 Apr 2025
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Drug Induced Liver Disease Study Group
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yimin Mao, Drug Induced Liver Disease Study Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06670391
- Sponsor's protocol ID
- GM_DILI_002
- Status last verified
- Apr 2025
- First submitted
- 29 Oct 2024
- Last updated
- 4 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective, Real-world, Electronic Medical Record-based Study on Patients With Liver Injury After the Administration of Novel Antineoplastic Agents
- ClinicalTrials.gov ID
- NCT06670391
- Acronym / sponsor ID
- GM_DILI_002
- Conditions
- Liver Injury, Liver Injury, Drug-Induced
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Drug Induced Liver Disease Study GroupUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 1 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All hospitalized patients from participating medical centers.
Key inclusion criteria (2 listed)
- Age ≥ 18 years
- Abnormality of liver biochemistry after the administration of any molecularly targeted agent or immune checkpoint inhibitor
Key exclusion criteria (2 listed)
- Missing major baseline or clinical data
- Prior liver loco-regional therapy or surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in ALT (alanine aminotransferase)
Time frame: on day 10
Absolute change
4 secondary outcomes
Proportion of patients with normalized liver biochemistry
Time frame: on day 3, 7, 10, 14, 21, and 30
Change in liver biochemistry
Time frame: on day 3, 7, 10, 14, 21, and 30
Time to normalization of liver biochemistry
Time frame: up to 6 month
Proportion of patients with ≥ 50% reduction in liver biochemistry
Time frame: on day 3, 7, 10, 14, 21, and 30
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Injury and Liver Injury, Drug-Induced, run by Drug Induced Liver Disease Study Group at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 4 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in ALT (alanine aminotransferase) (time frame: on day 10). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2025.