Efficacy and Safety of Polyene Phosphatidylcholine in Treatment of Patients With Acute Drug-induced Liver Injury
NCT ID: NCT04595916
Last Updated: 2020-11-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
73 participants
INTERVENTIONAL
2020-04-04
2020-11-02
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Polyene Phosphatidylcholine
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.
Magnesium Isoglycyrrhizinate
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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Sichuan Haisco Pharmaceutical Group Co., Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Yimin Mao, M.D.
Role: STUDY_CHAIR
RenJi Hospital
Locations
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The Second Hospital of Anhui Medical University
Hefei, Anhui, China
Beijing Chest Hospital of Capital Medical University
Beijing, Beijing Municipality, China
Mengchao Hepatobiliary Hospital of Fujian Medical University
Fuzhou, Fujian, China
Shenzhen People's Hospital
Shenzhen, Guangdong, China
The Sixth People's Hospital of Zhengzhou
Zhengzhou, Henan, China
The Third Hospital of Zhenjiang Affiliated Jiangsu University
Zhenjiang, Jiangsu, China
Renji Hospital
Shanghai, Shanghai Municipality, China
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, China
Tongji Hospital
Shanghai, Shanghai Municipality, China
Countries
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Other Identifiers
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HSK-28-201
Identifier Type: -
Identifier Source: org_study_id