Clinical trial NCT04595916: Efficacy and Safety of Polyene Phosphatidylcholine in Treatment of Patients With Acute Drug-induced Liver Injury
Official title: A Multicenter, Randomized, Single-blind, Active-controlled Trial of The Efficacy and Safety of Polyene Phosphatidylcholine in Patients With Acute Drug-induced Liver Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acute Drug Induced Liver Injury
Keywords: ADILI
Lead sponsor: Haisco Pharmaceutical Group Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2020-10-22
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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 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

Primary outcomes:
measure: Serum ALT normalization rate
timeFrame: After 2-4 weeks treatment
Secondary outcomes:
measure: The serum ALT normalization rate for 1, 2 and 3 weeks
timeFrame: After 1, 2 and 3 weeks treatment
measure: Changes in serum ALT compared to the baseline for 1, 2, 3 and 4 weeks
timeFrame: After 1, 2, 3 and 4 weeks treatment
measure: The ratio of subjects whose ALT declined more than 50% compared to the base line for 1, 2, 3 and 4 weeks
timeFrame: After 1, 2, 3 and 4 weeks treatment
measure: The serum AST normalization rate for 1, 2, 3 and 4 weeks
timeFrame: After 1, 2, 3 and 4 weeks treatment
measure: Changes in serum AST compared to the baseline for 1, 2, 3 and 4 weeks
timeFrame: After 1, 2, 3 and 4 weeks treatment
measure: The serum TBIL normalization rate for 1, 2, 3 and 4 weeks
timeFrame: After 1, 2, 3 and 4 weeks treatment
measure: Changes in serum TBIL compared to the baseline for 1, 2, 3 and 4 weeks
timeFrame: After 1, 2, 3 and 4 weeks treatment
measure: Changes in serum ALP and GGT compared to the baseline for 1, 2, 3 and 4 weeks
timeFrame: After 1, 2, 3 and 4 weeks treatment
measure: The Incidence of Treatment-Emergent Adverse Events over time
timeFrame: After 2 to 4 weeks of treatment and 1 week of safety follow-up
Other outcomes:
Locations:
city: Hefei
country: China
facility: The Second Hospital of Anhui Medical University
state: Anhui
city: Beijing
country: China
facility: Beijing Chest Hospital of Capital Medical University
state: Beijing
city: Fuzhou
country: China
facility: Mengchao Hepatobiliary Hospital of Fujian Medical University
state: Fujian
city: Shenzhen
country: China
facility: Shenzhen People's Hospital
state: Guangdong
city: Zhengzhou
country: China
facility: The Sixth People's Hospital of Zhengzhou
state: Henan
city: Zhenjiang
country: China
facility: The Third Hospital of Zhenjiang Affiliated Jiangsu University
state: Jiangsu
city: Shanghai
country: China
facility: Renji Hospital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Pulmonary Hospital
state: Shanghai
city: Shanghai
country: China
facility: Tongji Hospital
state: Shanghai
Study officials:
affiliation: RenJi Hospital
name: Yimin Mao, M.D.
role: STUDY_CHAIR
References: