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

Sichuan Haisco Pharmaceutical Group Co., Ltd9 sites in 1 country73 target enrollmentApril 4, 2020

ConditionsAcute Drug Induced Liver Injury

InterventionsPolyene phosphatidylcholine injection 930 mg QD Magnesium Isoglycyrrhizinate injection 200 mg QD

DrugsPolyene phosphatidylcholine injection 930 mg QD Magnesium Isoglycyrrhizinate injection 200 mg QD

Overview

Phase: Phase 4
Intervention: Polyene phosphatidylcholine injection 930 mg QD
Conditions: Acute Drug Induced Liver Injury
Sponsor: Sichuan Haisco Pharmaceutical Group Co., Ltd
Enrollment: 73
Locations: 9
Primary Endpoint: Serum ALT normalization rate
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Detailed 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.

Registry

clinicaltrials.gov

Start Date

April 4, 2020

End Date

November 2, 2020

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Sichuan Haisco Pharmaceutical Group Co., Ltd

Responsible Party

Sponsor

Eligibility 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

Arms & Interventions

Polyene Phosphatidylcholine

Intervention: Polyene phosphatidylcholine injection 930 mg QD

Magnesium Isoglycyrrhizinate

Intervention: Magnesium Isoglycyrrhizinate injection 200 mg QD

Outcomes

Primary Outcomes

Serum ALT normalization rate

Time Frame: After 2-4 weeks treatment

The serum ALT normalization rate of treatment for 2-4 weeks

Secondary Outcomes

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)
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)