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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01802996
Other study ID # MAGIC-301
Secondary ID
Status Recruiting
Phase Phase 4
First received February 26, 2013
Last updated October 29, 2013
Start date March 2013
Est. completion date August 2014

Study information

Verified date October 2013
Source Cttq
Contact Hua haiqing, MD
Phone 0086-025-80864049
Email huahaiqing@csco.org.cn
Is FDA regulated No
Health authority China: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


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 information / eligibility

Status Recruiting
Enrollment 2040
Est. completion date August 2014
Est. primary completion date August 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Drug:
Magnesium Isoglycyrrhizinate Injection
200mg IV on day 1-5

Locations

Country Name City State
China China PLA General Hospital Beijing Beijing
China The First Affiliated Hospital of General Hospital of PLA ( 304 ) Beijing Beijing
China Xiangya Hospital of Central South University Changsha Hunan
China Changzhou Second People's Hospital Changzhou Jiangsu
China Fujian Province-owned Hospital Fuzhou Fujian
China Fuzhou General Hospital of Nanjing Military Area Command Fuzhou Fujian
China Guangdong General Hospital Guangzhou Guangdong
China The First Affiliated Hospital of Guangzhou Medical College Guangzhou Guangdong
China Tumour Hospital Affiliated to Guangzhou Medical College Guangzhou Guangdong
China The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine Hefei Anhui
China The First Affiliated Hospital of Nanchang University Nanchang Jiangxi
China Nanjing General Hospital of Nanjing Military Area Command Nanjing Jiangsu
China The 81st hospital of PLA Nanjing Jiangsu
China The First Affiliated Hospital of Nanjing Medical University Nanjing Jiangsu
China The first hospital of Nanjing Nanjing Jiangsu
China The Second Affiliated Hospital of Nanjing Medical University Nanjing Jiangsu
China The Affiliated Tumor Hospital of Guangxi Medical University Nanning Guangxi
China The First Affiliated Hospital of Guangxi Medical University Nanning Guangxi
China Affiliated Hospital of Medical College of Qiingdao University Qingdao Shandong
China The first hospital of Hebei Medical University Shijiazhuang Hebei
China The second hospital of Hebei Medical University Shijiazhuang Hebei
China The people's Hospital of Wuhan University Wuhan Hubei
China The First Affiliated Hospital of Xinjiang Medical University Wulumuqi Xinjiang
China Wuxi Fourth People's Hospital Wuxi Jiangsu
China Wuxi People's Hospital Wuxi Jiangsu
China Affiliated Hospital of Xuzhou Medical College Xuzhou Jiangsu
China The First Affiliated Hospital of Zhengzhou University Zhengzhou Henan

Sponsors (1)

Lead Sponsor Collaborator
Cttq

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary The incidence of liver injury anyone of ALT?AST?ALP?TBIL?DBIL??-GT>ULN 0-15 days No
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