Evaluate the Efficacy of Magnesium Isoglycyrrhizinate in the Prevention of Chemotherapy Related Acute Liver Injury
NCT ID: NCT01802996
Last Updated: 2013-10-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE4
2040 participants
INTERVENTIONAL
2013-03-31
2014-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Arm I
Magnesium Isoglycyrrhizinate Injection 200mg IV on days 1-5
Magnesium Isoglycyrrhizinate Injection
200mg IV on day 1-5
Arm II
Only chemotherapy
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Magnesium Isoglycyrrhizinate Injection
200mg IV on day 1-5
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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.
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Cttq
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Qin Shukui, MD
Role: PRINCIPAL_INVESTIGATOR
The 81st hospital of PLA
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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, 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
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Zhou Jinhua
Role: primary
Wang Lijie
Role: primary
Ma Junxun
Role: primary
Lin Zhenhe
Role: primary
Chen Xi
Role: primary
Zheng Dengyun
Role: primary
Ouyang Ming
Role: primary
Chen Wensheng
Role: primary
Li Yongqiang
Role: primary
Lan Dong
Role: primary
An Yonghui
Role: primary
Xie Shaojian
Role: primary
Ma Wang
Role: primary
Yao Yi
Role: primary
Zhong Meizuo
Role: primary
Qian Keqin
Role: primary
Hua Haiqing, MD
Role: primary
Wang Rui
Role: primary
Zhu Lingjun
Role: primary
Chen Jinfei
Role: primary
Wang Keming
Role: primary
Hua Dong
Role: primary
Liu Chaoying
Role: primary
Xu Haiyang
Role: primary
Xiong Jianping
Role: primary
Qiu Wensheng
Role: primary
Zhang Hua
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
MAGIC-301
Identifier Type: -
Identifier Source: org_study_id