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

CTTQ

Status and phase: Completed; Phase 2

Conditions: Drug-Induced Liver Injury

Treatments: Drug: Tiopronin Injection; Drug: Magnesium Isoglycyrrhizinate Injection 100mg OD; Drug: Magnesium Isoglycyrrhizinate Injection 200mg OD

Study type: Interventional

Funder types: Industry

Identifiers

NCT02734966

ZTDQ01341301

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 174 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

174 participants in 3 patient groups

arm 1

Experimental group

Description:

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

Treatment:

Drug: Magnesium Isoglycyrrhizinate Injection 100mg OD

arm 2

Experimental group

Description:

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

Treatment:

Drug: Magnesium Isoglycyrrhizinate Injection 200mg OD

Tiopronin Injection

Active Comparator group

Description:

Tiopronin Injection 200mg OD for 4 weeks

Treatment:

Drug: Tiopronin Injection