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: 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
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.
- 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
- Rate of ALT normalization at week 4 of treatment
- Time Frame: 4 weeks
- 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
- 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.
- 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
- Lead Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Provider of Information About this Clinical Study
- Overall Official(s)
- Minde Zeng, MD, Principal Investigator, RenJi Hospital
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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