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

• Status: Completed
• Trial end date: 2020-11-02
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sichuan Haisco Pharmaceutical Group Co., Ltd; Sichuan Haisco Pharmaceutical Group Co., Ltd.
• Treatments: Polyene phosphatidylcholine

Criteria

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