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

Phase 2

Completed

• Conditions: Drug-Induced Liver Injury
• Interventions: Drug: Magnesium Isoglycyrrhizinate Injection 100mg OD; Drug: Magnesium Isoglycyrrhizinate Injection 200mg OD; Drug: Tiopronin Injection

• Registration Number: NCT02734966
• Lead Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2007-12
• Primary Completion: 2008-12
• Study Completion: 2011-12
• Study First Submitted: 2016-04-06
• Study First Submitted QC: 2016-04-06
• Study First Posted: 2016-04-12
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-25
• Last Update Posted: 2016-09-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 174

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
arm 1	Magnesium Isoglycyrrhizinate Injection 100mg OD	lower dose： Magnesium Isoglycyrrhizinate injection 100mg OD for 4 weeks
arm 2	Magnesium Isoglycyrrhizinate Injection 200mg OD	higher dose：Magnesium Isoglycyrrhizinate injection 200mg OD for 4 weeks.
Tiopronin Injection	Tiopronin Injection	Tiopronin Injection 200mg OD for 4 weeks

Primary Outcome Measures

Name	Time	Method
Rate of ALT normalization at week 4 of treatment	4 weeks

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (8)

Shanghai Sixth People's Hospital; 🇨🇳 Shanghai, Shanghai, China

Beijing Chest Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China

Nanjing Pulmonary Hospital; 🇨🇳 Nanjing, Jiangsu, China

85 Hospital of People's Liberation Army; 🇨🇳 Shanghai, Shanghai, China

Renji Hospital Shanghai Jiaotong University School of Medicine; 🇨🇳 Shanghai, Shanghai, China

Shanghai Pulmonary Hospital; 🇨🇳 Shanghai, Shanghai, China

Zhejiang Cancer Hospital; 🇨🇳 Hangzhou, Zhejiang, China

Integrated Chinese and Western Medicine Hospital of Zhejiang Province; 🇨🇳 Hangzhou, Zhejiang, China