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

March 7, 2020 updated by: Yao Xie, Beijing Ditan Hospital

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

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 Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100015
        • Department of Hepatology Division 2, Beijing Ditan Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The Department of Hepatology Division 2, Beijing Ditan Hospital, Capital Medical University was admitted and a liver biopsy was performed from 2014.9 to 2019.9. The patients were clearly diagnosed with drug-induced liver injury. These patients also met the RUCAM score and were diagnosed as DILI.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Patients with drug-induced liver injury
Patients who underwent liver biopsy and were diagnosed with drug-induced liver injury were diagnosed as DILI.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The rate of chronicity
Time Frame: 48 weeks
Chronic rate of drug-induced liver injury
48 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Ditan Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 1, 2020

Primary Completion (Anticipated)

April 30, 2021

Study Completion (Anticipated)

April 30, 2021

Study Registration Dates

First Submitted

March 7, 2020

First Submitted That Met QC Criteria

March 7, 2020

First Posted (Actual)

March 10, 2020

Study Record Updates

Last Update Posted (Actual)

March 10, 2020

Last Update Submitted That Met QC Criteria

March 7, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DTXY025

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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