Efficacy and Safety Study of Magnesium Isoglycyrrhizinate Injection in Subjects With Acute Drug-induced Liver Injury

Study Overview
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Brief Summary
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The purpose of this study is to investigate the safety, effective dosage and treatment of Magnesium Isolycyrrhizinate Injection to cure the acute drug-induced liver injury compared with the Tiopronin Injection.

Detailed Description
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The pharmacology research shows that Magnesium Isoglycyrrhizinate could significantly decrease the elevation of ALT and AST coursed by carbon tetrachloride, D-galactosamine and Thioacetamide. It could also significantly reduce the injury on the liver coursed by D-galacosamine and immunologic factors. Magnesium Isoglycyrrhizinate with strong anti-inflammatory effect could protect the liver cell and improve the liver function.

Official Title
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A Multi-center, Randomized, Double-blind, Active Control Phase II Study to Investigate Multiple Dosage and Treatments of Magnesium Isoglycyrrhizinate Injection to Cure the Acute Drug-induced Liver Injury

Conditions
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Drug-Induced Liver Injury

Intervention / Treatment
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* Drug: Magnesium Isoglycyrrhizinate Injection 100mg OD
* Drug: Magnesium Isoglycyrrhizinate Injection 200mg OD
* Drug: Tiopronin Injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: RACUM ≥6 ALTs ≥2ULN, but TBiL is ≤ 3 ULN.It may be associated with AST or ALP or TBiL exceed the upper limit of normal Liver biochemical abnormalities duration of no more than three months Patients need to fully understand and sign the inform consent form. Exclusion Criteria: The liver injury is caused by other diseases, such as virus hepatitis, alcohol and non-alcohol fatty liver disease or the autoimmune liver disease. The patients with the acute hepatic failure or hepatic decompensation, such as hepatic encephalopathy, ascites, albumin is ≤ 35g/L, prothrombin time is elongated more than 2 seconds compared to its normal range. The value of the TBiL is > 3ULN. The value of serum creatinine is > 1.5ULN. Patients who have severe organic diseases on heart, lungs, brain, kidney and gastrointestinal tract. Patients who are taking the drugs that might interfere the trial. Patients who are allergic or intolerant to the study drug. Patients who are not able to express the chief complaint, for example, the patients with psychosis and severe neurosis. Patients who are compliant with protocol. Women who are pregnant, breast-feeding or with childbearing potential. Patients who have attended other clinical trials within 3 months. Not appropriate to be included after assessing by the investigators. ULN=Upper Limited Normal

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: arm 1<br>lower dose： Magnesium Isoglycyrrhizinate injection 100mg OD for 4 weeks | Drug: Magnesium Isoglycyrrhizinate Injection 100mg OD<br>* Magnesium Isoglycyrrhizinate Injection 100mg OD<br>* Other names: Jiangsu Chia Tai Tianqing Pharmaceutical Group Co., Ltd.;|
| Experimental: arm 2<br>higher dose：Magnesium Isoglycyrrhizinate injection 200mg OD for 4 weeks. | Drug: Magnesium Isoglycyrrhizinate Injection 200mg OD<br>* Magnesium Isoglycyrrhizinate Injection 200mg OD for 4 weeks<br>* Other names: Jiangsu Chia Tai Tianqing Pharmaceutical Group Co., Ltd.;|
| Active Comparator: Tiopronin Injection<br>Tiopronin Injection 200mg OD for 4 weeks | Drug: Tiopronin Injection<br>* Tiopronin Injection 200mg OD<br>* Other names: Jinan Limin Pharmaceutical Co., Ltd.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of ALT normalization at week 4 of treatment |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rates of ALT normalization at weeks 1, 2, and 3 of treatment |  | 3 weeks | 
| change of ALT at weeks 1, 2, 3 and 4 of treatment; |  | 4 weeks | 
| change of AST at weeks 1, 2, 3 and 4 of treatment. |  | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Drug-Induced, Acute Liver Injury