Establishment of Drug-induced Liver Injury Databases and... | NCT02061826

Studies
Establishment of Drug-induced Liver Injury Databases and Application of Circulating microRNA(miRNA)

NCT02061826

Sponsor

Beijing Ditan Hospital

Status

Unknown status

Last Update Posted

Feb 19, 2014Estimated

Enrollment

800Estimated

Phase

Not provided

Conditions

Drug-induced Liver Injury

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2014

Primary Completion Date

Apr 2017Estimated

Completion Date

Apr 2017Estimated

First Submitted Date

Jan 26, 2014

First Submission Date that Met QC Criteria

Feb 12, 2014

First Posted Date

Feb 13, 2014Estimated

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

Feb 15, 2014

Last Update Posted Date

Feb 19, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

The purpose of the study is to establish drug-induced liver injury databases in China, make criteria for Chinese drug-induced liver injury patients and evaluate the application of certain circulating miRNA in diagnosis or treatment of drug-induced liver injury.

Detailed Description

Firstly, this study collects some retrospective data. Analyse these data and establish certain unique diagnostic criteria for Chinese. Then collect prospective data and validate the criteria. Otherwise,collect blood sample or other sample of the patients and study certain miRNA in diagnosis or treatment of drug-induced liver injury.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

3 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

800Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
histological features of drug-induced liver injury obtained by liver biopsy	Liver biopsy is the main method	within six months of the DILI onset date
clinical features of drug-induced liver injury assessed by serum parameters of liver function	serum parameters of liver function is the focus	participants will be followed for the duration of hospital stay, an expected average of 3 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Males and females between the age of 18 to 70 years
Women in child-bearing period taking some contraception measures
Patients with onset of acute liver injury attributed to antituberculosis drugs or antineoplastic drugs, Roussel Uclaf Causality Assessment Method（RUCAM ） score≥6
Written informed consent can be obtained, some patients agree with liver biopsy

Exclusion Criteria:

Viral hepatitis
Alcoholic liver disease or non-alcoholic liver disease
Wilson's disease or other inherited metabolic liver diseases
Auto-immune liver diseases
Any dysfunction of liver
Malnutrition
Chronic diseases such as HIV,severe heart diseases, severe brain diseases or chronic kidney diseases
Patients who can not complete follow-ups on time

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

community sample and primary care clinic

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Wen Xie, master	Contact	+86 84322816

Overall Officials

Name	Affiliation	Role
Wen Xie, master	Beijing Ditan Hospital	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Beijing Ditan Hospital		Beijing		100015	China

Condition Browse Module

MeSH Terms

ID	Term
D056486	Chemical and Drug Induced Liver Injury

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided