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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05060289
Other study ID # 2021-P2-290-01
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 25, 2022
Est. completion date December 31, 2026

Study information

Verified date October 2023
Source Beijing Friendship Hospital
Contact Yan Wang
Phone 18810530724
Email wangyanpku@163.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

A prospective, multi-center, non-interventional cohort study is going to conduct to explore the clinical characteristics, culprit drug(s) or herb(s), outcomes and risk factors of Drug-induced liver injury (DILI) in China and screen novel serum markers. A prognostic model incorporating with the novel serum marker(s) for DILI would be established and validated to imporve the prognosis of patients in China .


Description:

Research Objectives: 1. To establish a standardized multi-center, prospective DILI cohort nationwide and obtain long-term prognostic data. 2. To establish and verify prognostic model(s) of DILI in China. 3. To explore novel serum biomarkers for the prognosis of DILI.


Recruitment information / eligibility

Status Recruiting
Enrollment 3000
Est. completion date December 31, 2026
Est. primary completion date December 31, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. RUCAM =6 and met one of the following biochemical conditions: (1) ALT=5 ULN, (2) or ALP =2 ULN, (3) or ALT=3 ULN and TBil=2 ULN. 2. RUCAM between 3-5, five experienced hepatologists in leading site evaluate and vote the diagnosis of DILI, the case would be enrolled if only =4 out of 5 hepatologists agree with the diagnosis. 3. Onset to enrollment =3 months. Exclusion Criteria: 1. Hepatotropic viral infection: hepatitis A, B, C, D and E. 2. Non-hepatotropic viral infection: cytomegalovirus (CMV) and Epstein-Barr virus (EBV), etc. 3. Hypoxic ischemic hepatitis and congestive liver disease. 4. Alcohol consumption: male >40g/d, female >20g/d, and =5 years. 5. Biliary obstruction, primary biliary cholangitis; primary sclerosing cholangitis. 6. Autoimmune hepatitis: International Autoimmune Hepatitis Group (IAHG) simplified score =6 or complicated score =10, or differentiation from autoimmune hepatitis is impossible during enrollment. 7. Parasitic infection. 8. Sepsis. 9. Previous liver transplantation or bone marrow transplantation. 10. Pregnancy or lactation. 11. Genetic and metabolic liver diseases.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
China Beijing Friendship Hospital, Capital Medical University Beijing

Sponsors (1)

Lead Sponsor Collaborator
Beijing Friendship Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary acute liver failure Acute liver failure is defined as elevated bilirubin and prolonged international normalized ratio (INR) =1.5 accompanied by mental disturbance within 26 weeks after DILI onset without underlying chronic liver diseases. 1 year
Secondary chronic DILI Chronicity is defined as the presence of any one of the following: (i) persistently elevated liver biochemistry indexes; (ii) radiological or histological evidence of persistent liver injury at one year after DILI onset. 2 years
Secondary recovery Recovery status is defined as clinical and biochemical resolution within 1 year after DILI onset, with alanine aminotransferase (ALT) or aspartate aminotransferase (AST) =40 U/L, alkaline phosphatase (ALP) =150 U/L, and total bilirubin (TB) =1.5 upper limits of normal (ULN) (25.65 µmol/L). 2 years
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