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

• Conditions: Drug-induced Liver Injury

• Registration Number: NCT04302506
• Lead Sponsor: Beijing Ditan Hospital

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.

Study Timeline

• Status Verified: 2020-03
• Study First Submitted: 2020-03-07
• Study First Submitted QC: 2020-03-07
• Last Update Submitted: 2020-03-07
• Study First Posted: 2020-03-10
• Last Update Posted: 2020-03-10
• Study Start: 2020-04-01
• Primary Completion: 2021-04-30
• Study Completion: 2021-04-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 600

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The rate of chronicity	48 weeks	Chronic rate of drug-induced liver injury

Trial Locations

Locations (1)

Department of Hepatology Division 2, Beijing Ditan Hospital; 🇨🇳 Beijing, Beijing, China