Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Polyene Phosphatidylcholine | Experimental |
| |
| Magnesium Isoglycyrrhizinate | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Polyene phosphatidylcholine injection 930 mg QD | Drug | Polyene phosphatidylcholine injection 930mg, diluted with 5% glucose solution 250ml, once a day, at least 2 weeks but no more than 4 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Serum ALT normalization rate | The serum ALT normalization rate of treatment for 2-4 weeks | After 2-4 weeks treatment |
| Measure | Description | 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Yimin Mao, M.D. | RenJi Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Hospital of Anhui Medical University | Hefei | Anhui | China | |||
| Beijing Chest Hospital of Capital Medical University |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Magnesium Isoglycyrrhizinate injection 200 mg QD | Drug | Magnesium isoglycyrrhizinate injection 200mg, diluted with 5% glucose solution 250ml, once a day, at least 2 weeks but no more than 4 weeks. |
|
| 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 |
| The serum TBIL normalization rate 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 |
| 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 |
| ID | Term |
|---|---|
| D056486 | Chemical and Drug Induced Liver Injury |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D064420 | Drug-Related Side Effects and Adverse Reactions |
| D064419 | Chemically-Induced Disorders |
| D011041 | Poisoning |
Not provided
Not provided
| ID | Term |
|---|---|
| C029449 | polyene phosphatidylcholine |
| C521270 | 18alpha,20beta-hydroxy-11-oxo-norolean-12-en-3beta-yl-2-O-beta-D-glucopyranurosyl-alpha-D-glucopyranosiduronate magnesium tetrahydrate |
Not provided
Not provided
Not provided