Efficacy and Safety of Polyene Phosphatidylcholine in Treatment of Patients With Acute Drug-induc… (NCT04595916) | Clinical Trial Compass
CompletedPhase 4
Efficacy and Safety of Polyene Phosphatidylcholine in Treatment of Patients With Acute Drug-induced Liver Injury
China73 participantsStarted 2020-04-04
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
What they're measuring
1
Serum ALT normalization rate
Timeframe: After 2-4 weeks treatment
Trial details
NCT IDNCT04595916
SponsorSichuan Haisco Pharmaceutical Group Co., Ltd