Clinical trial NCT01802996: Evaluate the Efficacy of Magnesium Isoglycyrrhizinate in the Prevention of Chemotherapy Related Acute Liver Injury
Official title: A Randomized, Controlled, Multi-center Collaborative Study to Evaluate the Efficacy of Magnesium Isoglycyrrhizinate Injection in the Prevention of Antineoplastic Chemotherapy Related Acute Liver Injury
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Neoplasms
Liver Injury
Lead sponsor: Cttq
Sponsor class: INDUSTRY
First posted: 2013-03-04
Enrollment: 2040
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

1. Male or female aged 18-75 years;
2. Patients with malignant tumor accord with chemotherapy indication, candidate to a chemotherapy treatment, disease is not restricted;
3. 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;
4. ECOG≤2;
5. Estimates survival time≥3 months;
6. TBIL≤1.0×ULN, ALT、AST≤1.0×ULN; blood examination, uronoscopy, stool examination, renal function tests and electrocardiogram are normal;
7. Patients have been apart from the previous chemotherapy to finish above 2 weeks (including 2 weeks).

Exclusion Criteria:

1. Patients with partial liver radiotherapy;
2. Hepatitis B or C virus replication in the state, the patient will need antiviral therapy;
3. Patients have serious heart diseases, liver kidney diseases, or metabolism function disorder;
4. Patients combined with cellular immune therapy;
5. 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;
6. Pregnancy, or patients during breast feeding;
7. Patients have known hypersensitivity to Glycyrrhizin;
8. Patients are participating, or have participated in other Clinical studies of new drugs within 4 weeks.

Primary outcomes:
measure: The incidence of liver injury
timeFrame: 0-15 days
Secondary outcomes:
Other outcomes:
Locations:
city: Hefei
country: China
facility: The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine
state: Anhui
city: Beijing
country: China
facility: China PLA General Hospital
state: Beijing
city: Beijing
country: China
facility: The First Affiliated Hospital of General Hospital of PLA ( 304 )
state: Beijing
city: Fuzhou
country: China
facility: Fujian Province-owned Hospital
state: Fujian
city: Fuzhou
country: China
facility: Fuzhou General Hospital of Nanjing Military Area Command
state: Fujian
city: Guangzhou
country: China
facility: Guangdong General Hospital
state: Guangdong
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Guangzhou Medical College
state: Guangdong
city: Guangzhou
country: China
facility: Tumour Hospital Affiliated to Guangzhou Medical College
state: Guangdong
city: Nanning
country: China
facility: The Affiliated Tumor Hospital of Guangxi Medical University
state: Guangxi
city: Nanning
country: China
facility: The First Affiliated Hospital of Guangxi Medical University
state: Guangxi
city: Shijiazhuang
country: China
facility: The first hospital of Hebei Medical University
state: Hebei
city: Shijiazhuang
country: China
facility: The second hospital of Hebei Medical University
state: Hebei
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
state: Henan
city: Wuhan
country: China
facility: The people's Hospital of Wuhan University
state: Hubei
city: Changsha
country: China
facility: Xiangya Hospital of Central South University
state: Hunan
city: Changzhou
country: China
facility: Changzhou Second People's Hospital
state: Jiangsu
city: Nanjing
country: China
facility: The 81st hospital of PLA
state: Jiangsu
city: Nanjing
country: China
facility: Nanjing General Hospital of Nanjing Military Area Command
state: Jiangsu
city: Nanjing
country: China
facility: The First Affiliated Hospital of Nanjing Medical University
state: Jiangsu
city: Nanjing
country: China
facility: The first hospital of Nanjing
state: Jiangsu
city: Nanjing
country: China
facility: The Second Affiliated Hospital of Nanjing Medical University
state: Jiangsu
city: Wuxi
country: China
facility: Wuxi Fourth People's Hospital
state: Jiangsu
city: Wuxi
country: China
facility: Wuxi People's Hospital
state: Jiangsu
city: Xuzhou
country: China
facility: Affiliated Hospital of Xuzhou Medical College
state: Jiangsu
city: Nanchang
country: China
facility: The First Affiliated Hospital of Nanchang University
state: Jiangxi
city: Qingdao
country: China
facility: Affiliated Hospital of Medical College of Qiingdao University
state: Shandong
city: Wulumuqi
country: China
facility: The First Affiliated Hospital of Xinjiang Medical University
state: Xinjiang
Study officials:
affiliation: The 81st hospital of PLA
name: Qin Shukui, MD
role: PRINCIPAL_INVESTIGATOR
References: