NCT04595916

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 73 (actual)
• Sponsor: Sichuan Haisco Pharmaceutical Group Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Drug Induced Liver Injury

Interventions

Type	Name	Description
DRUG	Polyene phosphatidylcholine injection 930 mg QD	Polyene phosphatidylcholine injection 930mg, diluted with 5% glucose solution 250ml, once a day, at least 2 weeks but no more than 4 weeks.
DRUG	Magnesium Isoglycyrrhizinate injection 200 mg QD	Magnesium isoglycyrrhizinate injection 200mg, diluted with 5% glucose solution 250ml, once a day, at least 2 weeks but no more than 4 weeks.

Timeline

• Start date: 2020-04-04
• Primary completion: 2020-10-21
• Completion: 2020-11-02
• First posted: 2020-10-22
• Last updated: 2020-11-24

Locations

9 sites across 1 country: China