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The purpose of this study is to assess the safety and efficacy of glucocorticosteroid for treatment of drug-induced liver injury.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| glucocorticoid+hepatoprotectant group | Experimental | glucocorticoid 0.4mg/kg/d+hepatoprotectant for 7d |
|
| hepatoprotectant group | Active Comparator | hepatoprotectant for 7d |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glucocorticoids+hepatoprotectant | Drug | Participants received glucocorticoids (0.4mg/kg/d po.) and hepatoprotectant for 7 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| percentage of patients that AST or ALT decline 25% at day 4 | AST or ALT decline 25% at day 4 | Change from Baseline ALT and AST at day4 |
| Measure | Description | Time Frame |
|---|---|---|
| percentage of patients that AST or ALT decline 50% at day 8 | AST or ALT decline 25% at day 8 | Change from Baseline ALT and AST at day8 |
| the time needed when TBIL decline 50% | TBIL decline 50%; time |
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Inclusion Criteria:
Clinical diagnosis of DILI
RUCAM score≥6 and with liver histology
Meet any of the following conditions:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Division of Gastroenterology & Hepatology,West China Hospital,Sichuan University | Recruiting | Chengdu | Sichuan | 610041 | China |
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| 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 |
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| ID | Term |
|---|---|
| D011241 | Prednisone |
| D008775 | Methylprednisolone |
| ID | Term |
|---|---|
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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|
| hepatoprotectant | Drug | Participants received hepatoprotectants (i.v.gtt.) for 7 days. |
|
|
| up to 2 weeks |
| incidence of side effects | infection,uncontrolled hypertension or hyperglycemia | up to 2 years |
| relapse rate in 12 months after drug withdrawal | relapse rate | 12 months after drug withdrawal |
| mortality in 12 months after drug withdrawal | mortality | 12 months after drug withdrawal |
| D011041 | Poisoning |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D011239 | Prednisolone |
| D011246 | Pregnadienetriols |