NCT04595916已完成4 期
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 个研究点 分布在 1 个国家目标入组 73 人开始时间: 2020年4月4日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 73
- 试验地点
- 9
- 主要终点
- Serum ALT normalization rate
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Polyene Phosphatidylcholine
Experimental
干预措施: Polyene phosphatidylcholine injection 930 mg QD (Drug)
Magnesium Isoglycyrrhizinate
Active Comparator
干预措施: Magnesium Isoglycyrrhizinate injection 200 mg QD (Drug)
结局指标
主要结局
Serum ALT normalization rate
时间窗: After 2-4 weeks treatment
The serum ALT normalization rate of treatment for 2-4 weeks
次要结局
- 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)
研究者
研究点 (9)
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