Trials Sponsors Conditions Drugs Pricing

Conditions

Recurrent Drug-induced Liver Injury

Keywords

Genetic SusceptibilityHLAEndpoint Event(s)Drug-induced Liver Injury

Outcome Measures

Primary Outcomes (3)

Death/Liver transplantation
DILI has a primary, contributory role for the death (liver-related mortality) or no role for the death (all-cause mortality) . DILI is the primary indication for liver transplantation.
1 year
Acute Liver Failure
Acute liver failure is defined as elevated bilirubin and prolonged international normalized ratio (INR) ≥1.5 accompaniedby mental disturbance within 26 weeks after DILI onset without underlying chronic liver diseases.
1 year
Recovery
Recovery status is defined as clinical and biochemical resolution within 1 year after DILI onset, with alanineaminotransferase (ALT) or aspartate aminotransferase (AST) ≤40 U/L, alkaline phosphatase (ALP) ≤150 U/L, and totalbilirubin (TB) ≤1.5 upper limits of normal (ULN) (25.65 μmol/L).
1 year

Secondary Outcomes (1)

chronic DILI
2 years

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

Adult with recurrent drug-induced liver injury

You may qualify if:

Liver enzymes returns to normal or has a tendency to remission after the first drug liver injury;

Sponsors & Collaborators

Beijing Friendship Hospital
Otherlead

Study Sites (1)

Liver Research Center, Beijing Friendship Hospital, Key Laboratory on Translational Medicine on Cirrhosis, National Clinical Research Center for Digestive Disease, Capital Medical University, Beijing, China

Beijing, Beijing Municipality, 100050, China

Biospecimen

Retention: SAMPLES WITH DNA

Retrospective and Prospective study

MeSH Terms

Conditions

Chemical and Drug Induced Liver InjuryGenetic Predisposition to Disease

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesDrug-Related Side Effects and Adverse ReactionsChemically-Induced DisordersPoisoningDisease SusceptibilityDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

Xinyan Zhao
Beijing Friendship Hospital
STUDY CHAIR

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: OTHER
Target Duration: 2 Years
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Professor

Study Record Dates

First Submitted

August 7, 2024

First Posted

August 9, 2024

Study Start

July 15, 2024

Actual (reported)

Primary Completion

September 2026

Estimated (date passed)

Clinicopathological Features and Genetic Susceptibility Screening of Recurrent Drug-induced Liver Injury

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (1)

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Biospecimen

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (1)

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Biospecimen

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations