Efficacy and Safety of Polyene Phosphatidylcholine in Treatment of Patients With Acute Drug-induced Liver Injury

A Multicenter, Randomized, Single-blind, Active-controlled Trial of The Efficacy and Safety of Polyene Phosphatidylcholine in Patients With Acute Drug-induced Liver Injury

The purpose of this study is to explore the efficacy and the safety of polyene phosphatidylcholine Injection in patients with acute drug-induced liver injury after 2-4 weeks of treatment.

This study is a phase IV study in subjects with acute drug-induced liver injury. As designed, the study will include a screening period of up to 1 week, 2 to 4 weeks of treatment, and 1 week of safety follow-up. The eligible subjects will randomly be assigned to polyene phosphatidylcholine group or magnesium isoglycyrrhizinate group to receive single-blind treatment with a ratio of 1:1.

Inclusion Criteria:

• Age ≥ 18 and ≤ 75 years, Male or female patients
• Alanine aminotransferase (ALT) ≥ 3 x upper limit of normal (ULN) and Total bilirubin (TBIL) ≤ 5 x upper limit of normal (ULN)
• The Roussel Uclaf Causality Assessment Method (RUCAM) score is more than or equal to 6 points. The patients with RUCAM score of 3-5 needs to be determined by all three investigators that the liver injury is likely to be caused by drugs
• The duration of the current liver injury does not exceed 6 months

Exclusion Criteria:

• Liver injury caused by other diseases, such as viral hepatitis, alcoholic and non-alcoholic fatty liver disease, or autoimmune liver disease
• Acute liver failure or liver function decompensation, such as hepatic encephalopathy, ascites, albumin is less than 35g / L, the international standardized ratio (INR) of thrombin is more than 1.5
• Anemia or thrombocytopenia, hemoglobin is below 80 g/L, platelet count below 50,000 platelets per microliter
• Serum creatinine is more than 1.5 times ULN
• Severe hypokalemia, severe hypernatremia
• Patients have severe uncontrolled hypertension
• Severe diseases of vital organs such as heart, lung, brain, kidney, and gastrointestinal tract
• Treatment with polyene phosphatidylcholine injection or magnesium isoglycyrrhizinate injection within 5 days before informed consent
• Allergy or intolerance to benzyl alcohol and study drugs
• With no ability to express their complaints, such as mental illness and severe neurosis patient
• Pregnant or breastfeeding women, fertile women or men are reluctant to use contraception to avoid pregnancy during the trial
• Participation in another trial within 3 months before informed consent
• Patients who are considered by the investigator as inappropriate for the trial for other reasons