A Prognostic Model for Drug-induced Liver Injury in China

Drug-induced Liver Injury Clinical Trial

— DILI-PM  

Official title:

A Prognostic Model for Drug-induced Liver Injury in China : A Multi-center, Prospective Cohort Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05060289
• Other study ID #: 2021-P2-290-01
• Status: Recruiting
• 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
• 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.

Related Conditions & MeSH terms

• Chemical and Drug Induced Liver Injury
• Drug-induced Liver Injury
• Wounds and Injuries

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