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Correlative Cohort Study on the Clinical Features and Prognosis of Drug-induced Liver Injury

The Correlative Cohort Study on the Clinical Features and Prognosis of Drug-induced Liver Injury

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04302506
Enrollment
600
Registered
2020-03-10
Start date
2020-04-01
Completion date
2021-04-30
Last updated
2020-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Drug-induced Liver Injury

Keywords

Drug-induced liver injury, Chronic, regression analysis, ROC curve, Joint diagnosis

Brief summary

This was a retrospective study of a clinical observational cohort. The patients were admitted and definitely diagnosed by liver biopsy as drug-induced liver injury from September 2014 to September 2019, in the Second Department of Liver Disease, Beijing Ditan Hospital Affiliated to Capital Medical University were enrolled, and these patients also met the RUCAM score and were clinically diagnosed as DILI. Baseline clinical data and follow-up biochemical data at 3, 6, and 12 months were collected. SPSS software was used to analyze the characteristics of clinical data and the dynamic changes of biochemical indicators. Logistic regression was used to analyze the risk factors associated with the chronicity of DILI. Bivariate Logistic regression model and ROC curve were used to obtain the clinical indicators for combined diagnosis of chronicity of DILI patients. To investigate the clinical features and prognostic factors of drug-induced liver injury.

Detailed description

This was a retrospective study of a clinical observational cohort. The patients were admitted and definitely diagnosed by liver biopsy as drug-induced liver injury from September 2014 to September 2019, in the Second Department of Liver Disease, Beijing Ditan Hospital Affiliated to Capital Medical University were enrolled, and these patients also met the RUCAM score and were clinically diagnosed as DILI. Baseline clinical data and follow-up biochemical data at 3, 6, and 12 months were collected. SPSS software was used to analyze the characteristics of clinical data and the dynamic changes of biochemical indicators. Logistic regression was used to analyze the risk factors associated with the chronicity of DILI. Bivariate Logistic regression model and ROC curve were used to obtain the clinical indicators for combined diagnosis of chronicity of DILI patients. To investigate the clinical features and prognostic factors of drug-induced liver injury.

Interventions

None listed

Sponsors

Beijing Ditan Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* Have a clear history of taking drugs (Chinese herbal medicine and dietary supplements, NSAIDs, cardio-cerebrovascular drugs, anti-interference drugs, anti-tuberculosis drugs, hormone drugs and others); * All patients were examined by liver biopsy Patients with clear diagnosis of drug-induced liver injury and clinical diagnosis of DILI who meet the RUCAM score.

Exclusion criteria

* Combined with various liver diseases, such as viral hepatitis (hepatitis A, B, C, D, E), alcoholic hepatitis, autoimmune hepatitis, metabolic hepatitis, non-alcoholic fatty liver disease; * Combining other viral infections that may lose liver function, such as Epstein-Barr Virus (EBV), Cytomegalovirus (CMV), and Human Immunodeficiency Virus (HIV); * Mental illness; * Evidence of liver tumors (liver cancer or alpha-fetoprotein\> 100 ng / ml).

Design outcomes

Primary

MeasureTime frameDescription
The rate of chronicity48 weeksChronic rate of drug-induced liver injury

Countries

China

Contacts

Primary ContactYao Xie, Doctor
xieyao00120184@sina.com86-13501093293

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026