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

• Sponsor: Cttq (Industry)
• Overall Status: Unknown status
• CT.gov ID: NCT01802996
• Collaborator: (none)
• Enrollment: 2,040
• Locations: 27
• Arms: 2
• Duration (Months): 17
• Patients Per Site: 75.6
• Patients Per Site Per Month: 4.4

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Neoplasms; Liver Injury	Drug: Magnesium Isoglycyrrhizinate Injection	Phase 4

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 2040 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• 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 Start Date: Mar 1, 2013
• Anticipated Primary Completion Date: Aug 1, 2014
• Anticipated Study Completion Date: Aug 1, 2014

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. The incidence of liver injury [0-15 days]

   anyone of ALT、AST、ALP、TBIL、DBIL、γ-GT>ULN

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine	Hefei	Anhui	China
2	China PLA General Hospital	Beijing	Beijing	China
3	The First Affiliated Hospital of General Hospital of PLA ( 304 )	Beijing	Beijing	China
4	Fujian Province-owned Hospital	Fuzhou	Fujian	China
5	Fuzhou General Hospital of Nanjing Military Area Command	Fuzhou	Fujian	China
6	Guangdong General Hospital	Guangzhou	Guangdong	China
7	The First Affiliated Hospital of Guangzhou Medical College	Guangzhou	Guangdong	China
8	Tumour Hospital Affiliated to Guangzhou Medical College	Guangzhou	Guangdong	China
9	The Affiliated Tumor Hospital of Guangxi Medical University	Nanning	Guangxi	China
10	The First Affiliated Hospital of Guangxi Medical University	Nanning	Guangxi	China
11	The first hospital of Hebei Medical University	Shijiazhuang	Hebei	China
12	The second hospital of Hebei Medical University	Shijiazhuang	Hebei	China
13	The First Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan	China
14	The people's Hospital of Wuhan University	Wuhan	Hubei	China
15	Xiangya Hospital of Central South University	Changsha	Hunan	China
16	Changzhou Second People's Hospital	Changzhou	Jiangsu	China
17	The 81st hospital of PLA	Nanjing	Jiangsu	China	210000
18	Nanjing General Hospital of Nanjing Military Area Command	Nanjing	Jiangsu	China
19	The First Affiliated Hospital of Nanjing Medical University	Nanjing	Jiangsu	China
20	The first hospital of Nanjing	Nanjing	Jiangsu	China
21	The Second Affiliated Hospital of Nanjing Medical University	Nanjing	Jiangsu	China
22	Wuxi Fourth People's Hospital	Wuxi	Jiangsu	China
23	Wuxi People's Hospital	Wuxi	Jiangsu	China
24	Affiliated Hospital of Xuzhou Medical College	Xuzhou	Jiangsu	China
25	The First Affiliated Hospital of Nanchang University	Nanchang	Jiangxi	China
26	Affiliated Hospital of Medical College of Qiingdao University	Qingdao	Shandong	China
27	The First Affiliated Hospital of Xinjiang Medical University	Wulumuqi	Xinjiang	China

Sponsors and Collaborators

• Cttq

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Cttq
• ClinicalTrials.gov Identifier: NCT01802996
• Other Study ID Numbers: MAGIC-301
• First Posted: Mar 4, 2013
• Last Update Posted: Oct 30, 2013
• Last Verified: Oct 1, 2013

• Additional relevant MeSH terms: Wounds and Injuries

Study Results

No Results Posted as of Oct 30, 2013