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

Primary Purpose

Drug-Induced Liver Injury

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Magnesium Isoglycyrrhizinate Injection 100mg OD
Magnesium Isoglycyrrhizinate Injection 200mg OD
Tiopronin Injection
Sponsored by
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Drug-Induced Liver Injury focused on measuring Drug-Induced, Acute Liver Injury

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

arm 1

arm 2

Tiopronin Injection

Arm Description

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

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

Tiopronin Injection 200mg OD for 4 weeks

Outcomes

Primary Outcome Measures

Rate of ALT normalization at week 4 of treatment

Secondary Outcome Measures

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

Full Information

First Posted
April 6, 2016
Last Updated
September 25, 2016
Sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02734966
Brief Title
Efficacy and Safety Study of Magnesium Isoglycyrrhizinate Injection in Subjects With Acute Drug-induced Liver Injury
Official Title
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
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
December 2007 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Drug-Induced Liver Injury
Keywords
Drug-Induced, Acute Liver Injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
174 (Actual)

8. Arms, Groups, and Interventions

Arm Title
arm 1
Arm Type
Experimental
Arm Description
lower dose： Magnesium Isoglycyrrhizinate injection 100mg OD for 4 weeks
Arm Title
arm 2
Arm Type
Experimental
Arm Description
higher dose：Magnesium Isoglycyrrhizinate injection 200mg OD for 4 weeks.
Arm Title
Tiopronin Injection
Arm Type
Active Comparator
Arm Description
Tiopronin Injection 200mg OD for 4 weeks
Intervention Type
Drug
Intervention Name(s)
Magnesium Isoglycyrrhizinate Injection 100mg OD
Other Intervention Name(s)
Jiangsu Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Intervention Description
Magnesium Isoglycyrrhizinate Injection 100mg OD
Intervention Type
Drug
Intervention Name(s)
Magnesium Isoglycyrrhizinate Injection 200mg OD
Other Intervention Name(s)
Jiangsu Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Intervention Description
Magnesium Isoglycyrrhizinate Injection 200mg OD for 4 weeks
Intervention Type
Drug
Intervention Name(s)
Tiopronin Injection
Other Intervention Name(s)
Jinan Limin Pharmaceutical Co., Ltd.
Intervention Description
Tiopronin Injection 200mg OD
Primary Outcome Measure Information:
Title
Rate of ALT normalization at week 4 of treatment
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
rates of ALT normalization at weeks 1, 2, and 3 of treatment
Time Frame
3 weeks
Title
change of ALT at weeks 1, 2, 3 and 4 of treatment;
Time Frame
4 weeks
Title
change of AST at weeks 1, 2, 3 and 4 of treatment.
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Minde Zeng, MD
Organizational Affiliation
RenJi Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Chest Hospital, Capital Medical University
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Nanjing Pulmonary Hospital
City
Nanjing
State/Province
Jiangsu
Country
China
Facility Name
85 Hospital of People's Liberation Army
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
Renji Hospital Shanghai Jiaotong University School of Medicine
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
Shanghai Pulmonary Hospital
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
Shanghai Sixth People's Hospital
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
Integrated Chinese and Western Medicine Hospital of Zhejiang Province
City
Hangzhou
State/Province
Zhejiang
Country
China
Facility Name
Zhejiang Cancer Hospital
City
Hangzhou
State/Province
Zhejiang
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
9303497
Citation
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. doi: 10.1002/hep.510260319.
Results Reference
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PubMed Identifier
16496329
Citation
Watkins PB, Seeff LB. Drug-induced liver injury: summary of a single topic clinical research conference. Hepatology. 2006 Mar;43(3):618-31. doi: 10.1002/hep.21095.
Results Reference
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Efficacy and Safety Study of Magnesium Isoglycyrrhizinate Injection in Subjects With Acute Drug-induced Liver Injury

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