Acute Drug Induced Liver Injury
Conditions
Keywords
ADILI
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.
Interventions
DRUGPolyene 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.
DRUGMagnesium 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.
Sponsors
Sichuan Haisco Pharmaceutical Group Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serum ALT normalization rate | After 2-4 weeks treatment | The serum ALT normalization rate of treatment for 2-4 weeks |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| 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 TBIL normalization rate for 1, 2, 3 and 4 weeks | After 1, 2, 3 and 4 weeks treatment |
Countries
China
Outcome results
None listed