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

Haisco Pharmaceutical Group

Status and phase

Completed

Phase 4

Conditions

Acute Drug Induced Liver Injury

Treatments

Drug: Magnesium Isoglycyrrhizinate injection 200 mg QD

Drug: Polyene phosphatidylcholine injection 930 mg QD

Study type

Interventional

Funder types

Industry

Identifiers

NCT04595916

HSK-28-201

Details and patient eligibility

About

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.

Full description

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.

Enrollment

73 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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