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A prospective randomized controlled study for severe drug-induced liver injury

A prospective randomized controlled study for severe drug-induced liver injury

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900021738
Enrollment
Unknown
Registered
2019-03-07
Start date
2019-01-08
Completion date
Unknown
Last updated
2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Drug-induced Liver Injury

Interventions

The treatment group 1:Protect liver treatment+glucocorticoid
The control group1:Protect liver treatment
The treatment group 2:Protect liver treatment+glucocorticoid
The control group2:Protect liver treatment

Sponsors

Beijing Beijing You'an Hospital Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: Cholestasis type of severe drug-induced liver injury 1) Aged 18-70 years, gender not limited; 2) Criteria for diagnosis of cholestasis in drug-induced liver injury (2015 guidelines for drug-induced liver injury); 3) Total bilirubin 10*ULN above or >1mg/ day; 4) Sign the informed consent. Severe drug-induced liver injury with a tendency to liver failure 1) Aged 18-70 years, gender not limited; 2) Criteria for diagnosis of hepatocyte injury following drug-induced liver injury (2015 guidelines for drug-induced liver injury); 3) Total bilirubin 10*ULN above or rise >1mg/ day, 3-5 days PTA progressive decline more than 10%, or less than 60%, after vitamin K treatment ineffective; 4) Sign the informed consent.

Exclusion criteria

Exclusion criteria: 1) Glucocorticoid therapy for contraindications; 2) Other basic liver diseases (except fatty liver) : such as hepatitis b and c virus infection, cirrhosis, etc.; 3) Acute and subacute liver failure.

Design outcomes

Primary

MeasureTime frame
Days of total bilirubin decrease > 50%;case fatality rate;

Secondary

MeasureTime frame
Liver function;

Countries

China

Contacts

Public ContactZuopeng Fan

Beijing Beijing You'an Hospital Capital Medical University

yunji8131@sina.com+86 18601159126

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026