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

September 25, 2016 updated by: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

174

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China
        • Beijing Chest Hospital, Capital Medical University
    • Jiangsu
      • Nanjing, Jiangsu, China
        • Nanjing Pulmonary Hospital
    • Shanghai
      • Shanghai, Shanghai, China
        • Renji Hospital Shanghai Jiaotong University School of Medicine
      • Shanghai, Shanghai, China
        • Shanghai Pulmonary Hospital
      • Shanghai, Shanghai, China
        • Shanghai Sixth People's Hospital
      • Shanghai, Shanghai, China
        • 85 Hospital of People's Liberation Army
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • Zhejiang Cancer hospital
      • Hangzhou, Zhejiang, China
        • Integrated Chinese and Western Medicine Hospital of Zhejiang Province

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: arm 1
lower dose： Magnesium Isoglycyrrhizinate injection 100mg OD for 4 weeks
Drug: Magnesium Isoglycyrrhizinate Injection 100mg OD
Magnesium Isoglycyrrhizinate Injection 100mg OD
Other Names:
  • Jiangsu Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Experimental: arm 2
higher dose：Magnesium Isoglycyrrhizinate injection 200mg OD for 4 weeks.
Drug: Magnesium Isoglycyrrhizinate Injection 200mg OD
Magnesium Isoglycyrrhizinate Injection 200mg OD for 4 weeks
Other Names:
  • Jiangsu Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Active Comparator: Tiopronin Injection
Tiopronin Injection 200mg OD for 4 weeks
Drug: Tiopronin Injection
Tiopronin Injection 200mg OD
Other Names:
  • Jinan Limin Pharmaceutical Co., Ltd.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Investigators

  • Principal Investigator: Minde Zeng, MD, RenJi Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2007

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

April 6, 2016

First Submitted That Met QC Criteria

April 6, 2016

First Posted (Estimate)

April 12, 2016

Study Record Updates

Last Update Posted (Estimate)

September 27, 2016

Last Update Submitted That Met QC Criteria

September 25, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZTDQ01341301

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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