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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Acute Drug Induced Liver Injury

Intervention / Treatment
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* Drug: Polyene phosphatidylcholine injection 930 mg QD
* Drug: Magnesium Isoglycyrrhizinate injection 200 mg QD


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Polyene Phosphatidylcholine<br> | Drug: Polyene phosphatidylcholine injection 930 mg QD<br>* Polyene phosphatidylcholine injection 930mg, diluted with 5% glucose solution 250ml, once a day, at least 2 weeks but no more than 4 weeks.<br>|
| Active Comparator: Magnesium Isoglycyrrhizinate<br> | Drug: Magnesium Isoglycyrrhizinate injection 200 mg QD<br>* Magnesium isoglycyrrhizinate injection 200mg, diluted with 5% glucose solution 250ml, once a day, at least 2 weeks but no more than 4 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum ALT normalization rate | The serum ALT normalization rate of treatment for 2-4 weeks | After 2-4 weeks treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The serum ALT normalization rate for 1, 2 and 3 weeks |  | After 1, 2 and 3 weeks treatment | 
| Changes in serum ALT compared to the baseline for 1, 2, 3 and 4 weeks |  | After 1, 2, 3 and 4 weeks treatment | 
| The ratio of subjects whose ALT declined more than 50% compared to the base line for 1, 2, 3 and 4 weeks |  | After 1, 2, 3 and 4 weeks treatment | 
| The serum AST normalization rate for 1, 2, 3 and 4 weeks |  | After 1, 2, 3 and 4 weeks treatment | 
| Changes in serum AST compared to the baseline for 1, 2, 3 and 4 weeks |  | After 1, 2, 3 and 4 weeks treatment | 
| The serum TBIL normalization rate for 1, 2, 3 and 4 weeks |  | After 1, 2, 3 and 4 weeks treatment | 
| Changes in serum TBIL compared to the baseline for 1, 2, 3 and 4 weeks |  | After 1, 2, 3 and 4 weeks treatment | 
| Changes in serum ALP and GGT compared to the baseline for 1, 2, 3 and 4 weeks |  | After 1, 2, 3 and 4 weeks treatment | 
| The Incidence of Treatment-Emergent Adverse Events over time |  | After 2 to 4 weeks of treatment and 1 week of safety follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ADILI