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Evaluate the Efficacy of Magnesium Isoglycyrrhizinate in the Prevention of Chemotherapy Related Acute Liver Injury (MAGIC)

Primary Purpose

Neoplasms, Liver Injury

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Magnesium Isoglycyrrhizinate Injection
Sponsored by
Cttq
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Neoplasms

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The First Affiliated Hospital of Anhui University of Traditional Chinese MedicineRecruiting
  • China PLA General HospitalRecruiting
  • The First Affiliated Hospital of General Hospital of PLA ( 304 )Recruiting
  • Fujian Province-owned HospitalRecruiting
  • Fuzhou General Hospital of Nanjing Military Area CommandRecruiting
  • Guangdong General HospitalRecruiting
  • The First Affiliated Hospital of Guangzhou Medical CollegeRecruiting
  • Tumour Hospital Affiliated to Guangzhou Medical CollegeRecruiting
  • The Affiliated Tumor Hospital of Guangxi Medical UniversityRecruiting
  • The First Affiliated Hospital of Guangxi Medical UniversityRecruiting
  • The first hospital of Hebei Medical UniversityRecruiting
  • The second hospital of Hebei Medical UniversityRecruiting
  • The First Affiliated Hospital of Zhengzhou UniversityRecruiting
  • The people's Hospital of Wuhan UniversityRecruiting
  • Xiangya Hospital of Central South UniversityRecruiting
  • Changzhou Second People's HospitalRecruiting
  • The 81st hospital of PLARecruiting
  • Nanjing General Hospital of Nanjing Military Area CommandRecruiting
  • The First Affiliated Hospital of Nanjing Medical UniversityRecruiting
  • The first hospital of NanjingRecruiting
  • The Second Affiliated Hospital of Nanjing Medical UniversityRecruiting
  • Wuxi Fourth People's HospitalRecruiting
  • Wuxi People's HospitalRecruiting
  • Affiliated Hospital of Xuzhou Medical CollegeRecruiting
  • The First Affiliated Hospital of Nanchang UniversityRecruiting
  • Affiliated Hospital of Medical College of Qiingdao UniversityRecruiting
  • The First Affiliated Hospital of Xinjiang Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Arm I

Arm II

Arm Description

Magnesium Isoglycyrrhizinate Injection 200mg IV on days 1-5

Only chemotherapy

Outcomes

Primary Outcome Measures

The incidence of liver injury
anyone of ALT、AST、ALP、TBIL、DBIL、γ-GT>ULN

Secondary Outcome Measures

Full Information

First Posted
February 26, 2013
Last Updated
October 29, 2013
Sponsor
Cttq
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1. Study Identification

Unique Protocol Identification Number
NCT01802996
Brief Title
Evaluate the Efficacy of Magnesium Isoglycyrrhizinate in the Prevention of Chemotherapy Related Acute Liver Injury
Acronym
MAGIC
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

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Unknown status
Study Start Date
March 2013 (undefined)
Primary Completion Date
August 2014 (Anticipated)
Study Completion Date
August 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cttq

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neoplasms, Liver Injury

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2040 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm I
Arm Type
Experimental
Arm Description
Magnesium Isoglycyrrhizinate Injection 200mg IV on days 1-5
Arm Title
Arm II
Arm Type
No Intervention
Arm Description
Only chemotherapy
Intervention Type
Drug
Intervention Name(s)
Magnesium Isoglycyrrhizinate Injection
Other Intervention Name(s)
Tianqingganmei®, 2005S07127
Intervention Description
200mg IV on day 1-5
Primary Outcome Measure Information:
Title
The incidence of liver injury
Description
anyone of ALT、AST、ALP、TBIL、DBIL、γ-GT>ULN
Time Frame
0-15 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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). Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hua haiqing, MD
Phone
0086-025-80864049
Email
huahaiqing@csco.org.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Qin Shukui, MD
Organizational Affiliation
The 81st hospital of PLA
Official's Role
Principal Investigator
Facility Information:
Facility Name
The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine
City
Hefei
State/Province
Anhui
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhou Jinhua
Facility Name
China PLA General Hospital
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wang Lijie
Facility Name
The First Affiliated Hospital of General Hospital of PLA ( 304 )
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ma Junxun
Facility Name
Fujian Province-owned Hospital
City
Fuzhou
State/Province
Fujian
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lin Zhenhe
Facility Name
Fuzhou General Hospital of Nanjing Military Area Command
City
Fuzhou
State/Province
Fujian
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chen Xi
Facility Name
Guangdong General Hospital
City
Guangzhou
State/Province
Guangdong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zheng Dengyun
Facility Name
The First Affiliated Hospital of Guangzhou Medical College
City
Guangzhou
State/Province
Guangdong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ouyang Ming
Facility Name
Tumour Hospital Affiliated to Guangzhou Medical College
City
Guangzhou
State/Province
Guangdong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chen Wensheng
Facility Name
The Affiliated Tumor Hospital of Guangxi Medical University
City
Nanning
State/Province
Guangxi
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Li Yongqiang
Facility Name
The First Affiliated Hospital of Guangxi Medical University
City
Nanning
State/Province
Guangxi
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lan Dong
Facility Name
The first hospital of Hebei Medical University
City
Shijiazhuang
State/Province
Hebei
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
An Yonghui
Facility Name
The second hospital of Hebei Medical University
City
Shijiazhuang
State/Province
Hebei
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xie Shaojian
Facility Name
The First Affiliated Hospital of Zhengzhou University
City
Zhengzhou
State/Province
Henan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ma Wang
Facility Name
The people's Hospital of Wuhan University
City
Wuhan
State/Province
Hubei
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yao Yi
Facility Name
Xiangya Hospital of Central South University
City
Changsha
State/Province
Hunan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhong Meizuo
Facility Name
Changzhou Second People's Hospital
City
Changzhou
State/Province
Jiangsu
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qian Keqin
Facility Name
The 81st hospital of PLA
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hua Haiqing, MD
Phone
0086-025-80864049
Email
huahaiqing@csco.org.cn
First Name & Middle Initial & Last Name & Degree
Qin Shukui, MD
Facility Name
Nanjing General Hospital of Nanjing Military Area Command
City
Nanjing
State/Province
Jiangsu
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wang Rui
Facility Name
The First Affiliated Hospital of Nanjing Medical University
City
Nanjing
State/Province
Jiangsu
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhu Lingjun
Facility Name
The first hospital of Nanjing
City
Nanjing
State/Province
Jiangsu
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chen Jinfei
Facility Name
The Second Affiliated Hospital of Nanjing Medical University
City
Nanjing
State/Province
Jiangsu
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wang Keming
Facility Name
Wuxi Fourth People's Hospital
City
Wuxi
State/Province
Jiangsu
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hua Dong
Facility Name
Wuxi People's Hospital
City
Wuxi
State/Province
Jiangsu
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liu Chaoying
Facility Name
Affiliated Hospital of Xuzhou Medical College
City
Xuzhou
State/Province
Jiangsu
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xu Haiyang
Facility Name
The First Affiliated Hospital of Nanchang University
City
Nanchang
State/Province
Jiangxi
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiong Jianping
Facility Name
Affiliated Hospital of Medical College of Qiingdao University
City
Qingdao
State/Province
Shandong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qiu Wensheng
Facility Name
The First Affiliated Hospital of Xinjiang Medical University
City
Wulumuqi
State/Province
Xinjiang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhang Hua

12. IPD Sharing Statement

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Evaluate the Efficacy of Magnesium Isoglycyrrhizinate in the Prevention of Chemotherapy Related Acute Liver Injury

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