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

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.

Study Overview

• Status: Unknown
• Conditions: Neoplasms; Liver Injury
• Intervention / Treatment: Drug: Magnesium Isoglycyrrhizinate Injection

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.

• Study Type: Interventional
• Enrollment (Anticipated): 2040
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China
      • Recruiting
      • The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine
      • Contact: Zhou Jinhua
  • Beijing
    • Beijing, Beijing, China
      • Recruiting
      • China PLA General Hospital
      • Contact: Wang Lijie
    • Beijing, Beijing, China
      • Recruiting
      • The First Affiliated Hospital of General Hospital of PLA ( 304 )
      • Contact: Ma Junxun
  • Fujian
    • Fuzhou, Fujian, China
      • Recruiting
      • Fujian Province-owned Hospital
      • Contact: Lin Zhenhe
    • Fuzhou, Fujian, China
      • Recruiting
      • Fuzhou General Hospital of Nanjing Military Area Command
      • Contact: Chen Xi
  • Guangdong
    • Guangzhou, Guangdong, China
      • Recruiting
      • Guangdong General Hospital
      • Contact: Zheng Dengyun
    • Guangzhou, Guangdong, China
      • Recruiting
      • The First Affiliated Hospital of Guangzhou Medical College
      • Contact: Ouyang Ming
    • Guangzhou, Guangdong, China
      • Recruiting
      • Tumour Hospital Affiliated to Guangzhou Medical College
      • Contact: Chen Wensheng
  • Guangxi
    • Nanning, Guangxi, China
      • Recruiting
      • The First Affiliated Hospital of Guangxi Medical University
      • Contact: Lan Dong
    • Nanning, Guangxi, China
      • Recruiting
      • The Affiliated Tumor Hospital of Guangxi Medical University
      • Contact: Li Yongqiang
  • Hebei
    • Shijiazhuang, Hebei, China
      • Recruiting
      • The Second Hospital of Hebei Medical University
      • Contact: Xie Shaojian
    • Shijiazhuang, Hebei, China
      • Recruiting
      • The First Hospital of Hebei Medical University
      • Contact: An Yonghui
  • Henan
    • Zhengzhou, Henan, China
      • Recruiting
      • The First Affiliated Hospital of Zhengzhou University
      • Contact: Ma Wang
  • Hubei
    • Wuhan, Hubei, China
      • Recruiting
      • The people's Hospital of Wuhan University
      • Contact: Yao Yi
  • Hunan
    • Changsha, Hunan, China
      • Recruiting
      • Xiangya Hospital of Central South University
      • Contact: Zhong Meizuo
  • Jiangsu
    • Changzhou, Jiangsu, China
      • Recruiting
      • Changzhou Second People's Hospital
      • Contact: Qian Keqin
    • Nanjing, Jiangsu, China
      • Recruiting
      • The Second Affiliated Hospital of Nanjing Medical University
      • Contact: Wang Keming
    • Nanjing, Jiangsu, China
      • Recruiting
      • the First Affiliated Hospital of Nanjing Medical University
      • Contact: Zhu Lingjun
    • Nanjing, Jiangsu, China, 210000
      • Recruiting
      • The 81st hospital of PLA
      • Contact: Hua Haiqing, MD; Phone Number: 0086-025-80864049; Email: huahaiqing@csco.org.cn
      • Principal Investigator: Qin Shukui, MD
    • Nanjing, Jiangsu, China
      • Recruiting
      • Nanjing General Hospital of Nanjing Military Area Command
      • Contact: Wang Rui
    • Nanjing, Jiangsu, China
      • Recruiting
      • The First Hospital of Nanjing
      • Contact: Chen Jinfei
    • Wuxi, Jiangsu, China
      • Recruiting
      • Wuxi People's Hospital
      • Contact: Liu Chaoying
    • Wuxi, Jiangsu, China
      • Recruiting
      • Wuxi Fourth People's Hospital
      • Contact: Hua Dong
    • Xuzhou, Jiangsu, China
      • Recruiting
      • Affiliated hospital of Xuzhou medical college
      • Contact: Xu Haiyang
  • Jiangxi
    • Nanchang, Jiangxi, China
      • Recruiting
      • The First Affiliated Hospital of Nanchang University
      • Contact: Xiong Jianping
  • Shandong
    • Qingdao, Shandong, China
      • Recruiting
      • Affiliated Hospital of Medical College of Qiingdao University
      • Contact: Qiu Wensheng
  • Xinjiang
    • Wulumuqi, Xinjiang, China
      • Recruiting
      • The First Affiliated Hospital of Xinjiang Medical University
      • Contact: Zhang Hua

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm I; Magnesium Isoglycyrrhizinate Injection 200mg IV on days 1-5	Drug: Magnesium Isoglycyrrhizinate Injection; 200mg IV on day 1-5; Other Names: Tianqingganmei®; 2005S07127
No Intervention: Arm II; Only chemotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The incidence of liver injury	anyone of ALT、AST、ALP、TBIL、DBIL、γ-GT>ULN	0-15 days

Collaborators and Investigators

• Sponsor: Cttq
• Investigators: Principal Investigator: Qin Shukui, MD, The 81st hospital of PLA

Study record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (Anticipated): August 1, 2014
• Study Completion (Anticipated): August 1, 2014

Study Registration Dates

• First Submitted: February 26, 2013
• First Submitted That Met QC Criteria: February 28, 2013
• First Posted (Estimate): March 4, 2013

Study Record Updates

• Last Update Posted (Estimate): October 30, 2013
• Last Update Submitted That Met QC Criteria: October 29, 2013
• Last Verified: October 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: MAGIC-301