Clinical study on the efficacy and safety of polyene phosphatidylcholine injection in the treatment of drug-induced liver injury

The efficacy and safety of polyene phosphatidylcholine injection in the treatment of drug-induced liver injury

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2400086918

Enrollment

Unknown

Registered

2024-07-15

Start date

2024-07-15

Completion date

Unknown

Last updated

2024-07-22

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

prospective full dose group:The subjects received full dose treatment with polyene phosphatidylcholine injection

historical conventional dose group:The subjects received routine dose treatment of polyene phosphatidylcholine injection

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: (1) Age: 18-70 years old, regardless of gender; (2) In line with the clinical diagnosis of drug-induced liver injury, the score of RUCAM causal relationship evaluation scale was = 6, and the severity was 1-3; (3) Serum total bilirubin (TBIL) =2ULN and < 20 ULN; (4) Serum ALT = 3ULN; (5) The duration of the illness should not exceed 90 days; (6) Able to understand and sign informed consent.

Exclusion criteria

Exclusion criteria: (1)The liver injury is caused by other causes (such as viral hepatitis, alcoholic liver disease, and non-alcoholic fatty liver disease); (2)Have used any Chinese medicine or chemical with definite liver protection effect in the last 1 week; (3)Patients with acute liver failure or liver decompensation, such as hepatic encephalopathy, ascites, albumin = 35 g/L, and prothrombin time International normalized ratio (INR) greater than 1.5; (4)Blood creatinine is more than 1.5 times the upper limit of normal value; (5)White blood cell count (WBC) < 3.0×109/L or platelet count (PLT) < 50×109/L; (6)Patients with severe cardiovascular, renal, endocrine, hematological, nervous system diseases and psychosis; (7)Allergic to the investigational drug; (8)Pregnant and lactating women; (9)Participants who had participated in other clinical trials within 3 months prior to screening; (10)The researchers considered any ineligibility for inclusion.

Design outcomes

Primary

Measure	Time frame
ALT;	—

Secondary

Measure	Time frame
AST;TBIL;ALP;GGT;	—

Countries

China

Contacts

Public ContactYu Chen

Beijing You'an Hospital Affiliated to Capital Medical University

chybeyond1071@ccmu.edu.cn+86 10 8399 7000

Outcome results

None listed

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