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

Drug-Induced Liver Injury Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02734966
• Other study ID #: ZTDQ01341301
• Status: Completed
• Phase: Phase 2
• First received: April 6, 2016
• Last updated: September 25, 2016
• Start date: December 2007
• Est. completion date: December 2011

Study information

• Verified date: September 2016
• Source: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 174
• Est. completion date: December 2011
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Drug-Induced Liver Injury
• Wounds and Injuries

Intervention

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

Locations

Country	Name	City	State
China	Beijing Chest Hospital, Capital Medical University	Beijing	Beijing
China	Integrated Chinese and Western Medicine Hospital of Zhejiang Province	Hangzhou	Zhejiang
China	Zhejiang Cancer Hospital	Hangzhou	Zhejiang
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	Shanghai Sixth People's Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Country where clinical trial is conducted

China, 

References & Publications (2)

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. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of ALT normalization at week 4 of treatment		4 weeks	No
Secondary	rates of ALT normalization at weeks 1, 2, and 3 of treatment		3 weeks	No
Secondary	change of ALT at weeks 1, 2, 3 and 4 of treatment;		4 weeks	No
Secondary	change of AST at weeks 1, 2, 3 and 4 of treatment.		4 weeks	No