Trial | NCT02734966  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    174
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.
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.
Study Started
Dec 31
2007
Primary Completion
Dec 31
2008
Study Completion
Dec 31
2011
Last Update
Sep 27
2016
Estimate

Drug Magnesium Isoglycyrrhizinate Injection 100mg OD

Magnesium Isoglycyrrhizinate Injection 100mg OD

  • Other names: Jiangsu Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Drug Magnesium Isoglycyrrhizinate Injection 200mg OD

Magnesium Isoglycyrrhizinate Injection 200mg OD for 4 weeks

  • Other names: Jiangsu Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Drug Tiopronin Injection

Tiopronin Injection 200mg OD

  • Other names: Jinan Limin Pharmaceutical Co., Ltd.

arm 1 Experimental

lower dose： Magnesium Isoglycyrrhizinate injection 100mg OD for 4 weeks

arm 2 Experimental

higher dose：Magnesium Isoglycyrrhizinate injection 200mg OD for 4 weeks.

Tiopronin Injection Active Comparator

Tiopronin Injection 200mg OD for 4 weeks

Criteria 

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
No Results Posted