Evaluate the Efficacy of Magnesium Isoglycyrrhizinate in the Prevention of Chemotherapy Related Acute Liver Injury
- Registration Number
- NCT01802996
- Lead Sponsor
- Cttq
- Brief Summary
This purpose of this study is to evaluate the evaluate the efficacy of Magnesium Isoglycyrrhizinate Injection in the prevention of antineoplastic chemotherapy related acute liver injury.
- Detailed Description
Total subjects: 2040, experimental group of 1360 patients, control group of 680 patients. According to the study subjects receiving antineoplastic chemotherapy, subjects are stratified randomize.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 2040
- Male or female aged 18-75 years;
- Patients with malignant tumor accord with chemotherapy indication, candidate to a chemotherapy treatment, disease is not restricted;
- Accorded with the following chemotherapy plan: included cis-platinum, ≥60mg/m2/course; included oxaliplatin, ≥85mg/m2/course; included cyclophosphamide, ≥600mg/m2/course; included gemcitabine, ≥60mg/m2/course;
- ECOG≤2;
- Estimates survival time≥3 months;
- TBIL≤1.0×ULN, ALT、AST≤1.0×ULN; blood examination, uronoscopy, stool examination, renal function tests and electrocardiogram are normal;
- Patients have been apart from the previous chemotherapy to finish above 2 weeks (including 2 weeks).
- Patients with partial liver radiotherapy;
- Hepatitis B or C virus replication in the state, the patient will need antiviral therapy;
- Patients have serious heart diseases, liver kidney diseases, or metabolism function disorder;
- Patients combined with cellular immune therapy;
- Within 2 weeks of application or currently possible applications of drugs(polyene phosphatidylcholine, reduced glutathione, tiopronin and other hepatoprotective and choleretic drugs), interference with the study;
- Pregnancy, or patients during breast feeding;
- Patients have known hypersensitivity to Glycyrrhizin;
- Patients are participating, or have participated in other Clinical studies of new drugs within 4 weeks.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm I Magnesium Isoglycyrrhizinate Injection Magnesium Isoglycyrrhizinate Injection 200mg IV on days 1-5
- Primary Outcome Measures
Name Time Method The incidence of liver injury 0-15 days anyone of ALT、AST、ALP、TBIL、DBIL、γ-GT\>ULN
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (27)
The first hospital of Nanjing
🇨🇳Nanjing, Jiangsu, China
The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine
🇨🇳Hefei, Anhui, China
China PLA General Hospital
🇨🇳Beijing, Beijing, China
Fujian Province-owned Hospital
🇨🇳Fuzhou, Fujian, China
Fuzhou General Hospital of Nanjing Military Area Command
🇨🇳Fuzhou, Fujian, China
The First Affiliated Hospital of Guangzhou Medical College
🇨🇳Guangzhou, Guangdong, China
The Affiliated Tumor Hospital of Guangxi Medical University
🇨🇳Nanning, Guangxi, China
The First Affiliated Hospital of Guangxi Medical University
🇨🇳Nanning, Guangxi, China
The first hospital of Hebei Medical University
🇨🇳Shijiazhuang, Hebei, China
The people's Hospital of Wuhan University
🇨🇳Wuhan, Hubei, China
Changzhou Second People's Hospital
🇨🇳Changzhou, Jiangsu, China
The First Affiliated Hospital of Nanchang University
🇨🇳Nanchang, Jiangxi, China
The 81st hospital of PLA
🇨🇳Nanjing, Jiangsu, China
The Second Affiliated Hospital of Nanjing Medical University
🇨🇳Nanjing, Jiangsu, China
The First Affiliated Hospital of General Hospital of PLA ( 304 )
🇨🇳Beijing, Beijing, China
Guangdong General Hospital
🇨🇳Guangzhou, Guangdong, China
The second hospital of Hebei Medical University
🇨🇳Shijiazhuang, Hebei, China
The First Affiliated Hospital of Zhengzhou University
🇨🇳Zhengzhou, Henan, China
Tumour Hospital Affiliated to Guangzhou Medical College
🇨🇳Guangzhou, Guangdong, China
Xiangya Hospital of Central South University
🇨🇳Changsha, Hunan, China
Wuxi Fourth People's Hospital
🇨🇳Wuxi, Jiangsu, China
Nanjing General Hospital of Nanjing Military Area Command
🇨🇳Nanjing, Jiangsu, China
The First Affiliated Hospital of Nanjing Medical University
🇨🇳Nanjing, Jiangsu, China
Wuxi People's Hospital
🇨🇳Wuxi, Jiangsu, China
Affiliated Hospital of Xuzhou Medical College
🇨🇳Xuzhou, Jiangsu, China
Affiliated Hospital of Medical College of Qiingdao University
🇨🇳Qingdao, Shandong, China
The First Affiliated Hospital of Xinjiang Medical University
🇨🇳Wulumuqi, Xinjiang, China