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

Overview

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 Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: December 2008

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.

Interventions

  • Drug: Magnesium Isoglycyrrhizinate Injection 100mg OD
    • Magnesium Isoglycyrrhizinate Injection 100mg OD
  • Drug: Magnesium Isoglycyrrhizinate Injection 200mg OD
    • Magnesium Isoglycyrrhizinate Injection 200mg OD for 4 weeks
  • Drug: Tiopronin Injection
    • Tiopronin Injection 200mg OD

Arms, Groups and Cohorts

  • Experimental: arm 1
    • lower dose: Magnesium Isoglycyrrhizinate injection 100mg OD for 4 weeks
  • Experimental: arm 2
    • higher dose:Magnesium Isoglycyrrhizinate injection 200mg OD for 4 weeks.
  • Active Comparator: Tiopronin Injection
    • Tiopronin Injection 200mg OD for 4 weeks

Clinical Trial Outcome Measures

Primary Measures

  • Rate of ALT normalization at week 4 of treatment
    • Time Frame: 4 weeks

Secondary Measures

  • rates of ALT normalization at weeks 1, 2, and 3 of treatment
    • Time Frame: 3 weeks
  • change of ALT at weeks 1, 2, 3 and 4 of treatment;
    • Time Frame: 4 weeks
  • change of AST at weeks 1, 2, 3 and 4 of treatment.
    • Time Frame: 4 weeks

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Minde Zeng, MD, Principal Investigator, RenJi Hospital

References

Maria VA, Victorino RM. Development and validation of a clinical scale for the diagnosis of drug-induced hepatitis. Hepatology. 1997 Sep;26(3):664-9.

Watkins PB, Seeff LB. Drug-induced liver injury: summary of a single topic clinical research conference. Hepatology. 2006 Mar;43(3):618-31.

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