Efficacy and Safety of Polyene Phosphatidylcholine in Treatment of Patients With Acute Drug-induced Liver Injury
- Conditions
- Acute Drug Induced Liver Injury
- Interventions
- Drug: Magnesium Isoglycyrrhizinate injection 200 mg QD
- Registration Number
- NCT04595916
- Lead Sponsor
- Sichuan Haisco Pharmaceutical Group Co., Ltd
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 73
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Magnesium Isoglycyrrhizinate Magnesium Isoglycyrrhizinate injection 200 mg QD - Polyene Phosphatidylcholine Polyene phosphatidylcholine injection 930 mg QD -
- Primary Outcome Measures
Name Time Method Serum ALT normalization rate After 2-4 weeks treatment The serum ALT normalization rate of treatment for 2-4 weeks
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (9)
The Second Hospital of Anhui Medical University
🇨🇳Hefei, Anhui, China
Mengchao Hepatobiliary Hospital of Fujian Medical University
🇨🇳Fuzhou, Fujian, China
Shanghai Pulmonary Hospital
🇨🇳Shanghai, Shanghai, China
Beijing Chest Hospital of Capital Medical University
🇨🇳Beijing, Beijing, China
The Sixth People's Hospital of Zhengzhou
🇨🇳Zhengzhou, Henan, China
The Third Hospital of Zhenjiang Affiliated Jiangsu University
🇨🇳Zhenjiang, Jiangsu, China
Shenzhen People's Hospital
🇨🇳Shenzhen, Guangdong, China
Renji Hospital
🇨🇳Shanghai, Shanghai, China
Tongji Hospital
🇨🇳Shanghai, Shanghai, China