Evaluate the Efficacy of Magnesium Isoglycyrrhizinate in the Prevention of Chemotherapy Related Acute Liver Injury
MAGIC
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
1 other identifier
interventional
2,040
1 country
27
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Mar 2013
27 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 26, 2013
CompletedStudy Start
First participant enrolled
March 1, 2013
CompletedFirst Posted
Study publicly available on registry
March 4, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2014
CompletedOctober 30, 2013
October 1, 2013
1.4 years
February 26, 2013
October 29, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
The incidence of liver injury
anyone of ALT、AST、ALP、TBIL、DBIL、γ-GT\>ULN
0-15 days
Study Arms (2)
Arm I
EXPERIMENTALMagnesium Isoglycyrrhizinate Injection 200mg IV on days 1-5
Arm II
NO INTERVENTIONOnly chemotherapy
Interventions
200mg IV on day 1-5
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cttqlead
Study Sites (27)
The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine
Hefei, Anhui, China
China PLA General Hospital
Beijing, Beijing Municipality, China
The First Affiliated Hospital of General Hospital of PLA ( 304 )
Beijing, Beijing Municipality, 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 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 second hospital of Hebei Medical University
Shijiazhuang, Hebei, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
The people's Hospital of Wuhan University
Wuhan, Hubei, China
Xiangya Hospital of Central South University
Changsha, Hunan, China
Changzhou Second People's Hospital
Changzhou, Jiangsu, China
The 81st hospital of PLA
Nanjing, Jiangsu, 210000, China
Nanjing General Hospital of Nanjing Military Area Command
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
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 Nanchang University
Nanchang, Jiangxi, China
Affiliated Hospital of Medical College of Qiingdao University
Qingdao, Shandong, China
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, China
MeSH Terms
Conditions
Interventions
Study Officials
- PRINCIPAL INVESTIGATOR
Qin Shukui, MD
The 81st hospital of PLA
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 26, 2013
First Posted
March 4, 2013
Study Start
March 1, 2013
Primary Completion
August 1, 2014
Study Completion
August 1, 2014
Last Updated
October 30, 2013
Record last verified: 2013-10