Clinical trial NCT02734966: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Drug-Induced Liver Injury
Keywords: Drug-Induced
Acute Liver Injury
Lead sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2016-04-12
Enrollment: 174
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Rate of ALT normalization at week 4 of treatment
timeFrame: 4 weeks
Secondary outcomes:
measure: rates of ALT normalization at weeks 1, 2, and 3 of treatment
timeFrame: 3 weeks
measure: change of ALT at weeks 1, 2, 3 and 4 of treatment;
timeFrame: 4 weeks
measure: change of AST at weeks 1, 2, 3 and 4 of treatment.
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Chest Hospital, Capital Medical University
state: Beijing
city: Nanjing
country: China
facility: Nanjing Pulmonary Hospital
state: Jiangsu
city: Shanghai
country: China
facility: 85 Hospital of People's Liberation Army
state: Shanghai
city: Shanghai
country: China
facility: Renji Hospital Shanghai Jiaotong University School of Medicine
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Pulmonary Hospital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Sixth People's Hospital
state: Shanghai
city: Hangzhou
country: China
facility: Integrated Chinese and Western Medicine Hospital of Zhejiang Province
state: Zhejiang
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
Study officials:
affiliation: RenJi Hospital
name: Minde Zeng, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.