A Retrospective Study on Drug Induced Liver Injury in China | NCT02407964

Status Module

Record Verification Date

Oct 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2015

Primary Completion Date

May 2016Actual

Completion Date

Jul 2016Actual

First Submitted Date

Mar 31, 2015

First Submission Date that Met QC Criteria

Mar 31, 2015

First Posted Date

Apr 3, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 24, 2016

Last Update Posted Date

Oct 26, 2016Estimated

Name	Class
Unimed Scientific Inc.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This is a multi-center, open-enrollment, retrospective, non-interventional epidemiologic study without any clinical treatment. Its primary objective is to understand 1) incidence of drug-induced liver injury, including incidences among all the hospitalized patient, among patients in department of hepatic diseases, digestive diseases, oncology, hematology etc., individually; 2) epidemiologic characteristics of drug-induced liver injury, including suspected medications, clinical types, histological characteristics, severity and outcomes.

Detailed Description

It investigates medical records of patients who were hospitalized during 2012 to 2014. Those patients should be diagnosed as drug-induced liver injury, drug-induced liver disease, drug-induced hepatitis, drug-induced hepatocirrhosis, drug-induced hepatic failure, or any other similar diagnosis of drug-induced liver injury nature.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

15,000Actual

Measure	Description	Time Frame
diagnosis of drug-induced liver injury		6 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Any hospitalized patients who were diagnosed as drug-induced liver injury, drug-induced liver disease, drug-induced hepatitis, drug-induced hepatocirrhosis, drug-induced hepatic failure, or any other similar diagnosis of drug-induced liver injury nature.
The drug-induced liver injury and similar diagnosis were not excluded the possibility of drug-induced nature.

Exclusion Criteria:

Confirmed non-drug induced liver injury.
Insufficient clinical data supporting the diagnosis of drug-induced liver injury.
Liver injury resulted from poisons and chemicals.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients who were hospitalized during 2012 to 2014.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Yimin Mao, MD	RenJi Hospital	Study Chair
Chengwei Chen, MD	No. 85 Hospital of PLA	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of gastroenterology,the second hospital of Shanxi medical university		Taiyuan	Shanxi		China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
34521298	Derived	Li J, Zhang J, Xu X, Fang W, Qu S, Jin F, Zhou J, Han X, Raza HK, Li X, Mao Y. Hugan tablets for the treatment of RUCAM based drug-induced liver injury: a propensity score matching analysis using a nationwide database. Expert Rev Clin Pharmacol. 2021 Dec;14(12):1543-1550. doi: 10.1080/17512433.2021.1981859. Epub 2021 Sep 22.

ID	Term
D008107	Liver Diseases
D004066	Digestive System Diseases
D064420	Drug-Related Side Effects and Adverse Reactions
D064419	Chemically-Induced Disorders
D011041	Poisoning