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

Neoplasms Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01802996
• Other study ID #: MAGIC-301
• 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

• Liver Injury
• Neoplasms

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