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

• Status: Completed
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

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