Acute Drug Induced Liver Injury Clinical Trial
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
| Verified date | November 2020 |
| Source | Haisco Pharmaceutical Group Co., Ltd. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 73 |
| Est. completion date | November 2, 2020 |
| Est. primary completion date | October 21, 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 75 Years |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| China | Beijing Chest Hospital of Capital Medical University | Beijing | Beijing |
| China | Mengchao Hepatobiliary Hospital of Fujian Medical University | Fuzhou | Fujian |
| China | The Second Hospital of Anhui Medical University | Hefei | Anhui |
| China | Renji Hospital | Shanghai | Shanghai |
| China | Shanghai Pulmonary Hospital | Shanghai | Shanghai |
| China | Tongji Hospital | Shanghai | Shanghai |
| 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 |
| Lead Sponsor | Collaborator |
|---|---|
| Sichuan Haisco Pharmaceutical Group Co., Ltd |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Serum ALT normalization rate | The serum ALT normalization rate of treatment for 2-4 weeks | After 2-4 weeks treatment | |
| Secondary | The serum ALT normalization rate for 1, 2 and 3 weeks | After 1, 2 and 3 weeks treatment | ||
| Secondary | Changes in serum ALT compared to the baseline for 1, 2, 3 and 4 weeks | After 1, 2, 3 and 4 weeks treatment | ||
| Secondary | 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 | ||
| Secondary | The serum AST normalization rate for 1, 2, 3 and 4 weeks | After 1, 2, 3 and 4 weeks treatment | ||
| Secondary | Changes in serum AST compared to the baseline for 1, 2, 3 and 4 weeks | After 1, 2, 3 and 4 weeks treatment | ||
| Secondary | The serum TBIL normalization rate for 1, 2, 3 and 4 weeks | After 1, 2, 3 and 4 weeks treatment | ||
| Secondary | Changes in serum TBIL compared to the baseline for 1, 2, 3 and 4 weeks | After 1, 2, 3 and 4 weeks treatment | ||
| Secondary | 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 | ||
| Secondary | The Incidence of Treatment-Emergent Adverse Events over time | After 2 to 4 weeks of treatment and 1 week of safety follow-up |