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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified October 2013 by Cttq.
Recruitment status was: Recruiting

Sponsor:

Information provided by (Responsible Party):

Cttq

ClinicalTrials.gov Identifier:

NCT01802996

First received: February 26, 2013

Last updated: October 29, 2013

Last verified: October 2013

History of Changes

Purpose

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	Intervention	Phase
Neoplasms Liver Injury	Drug: Magnesium Isoglycyrrhizinate Injection	Phase 4


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: 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

Resource links provided by NLM:

Drug Information available for: Magnesium

U.S. FDA Resources

Further study details as provided by Cttq:

Primary Outcome Measures:

The incidence of liver injury [ Time Frame: 0-15 days ]
anyone of ALT、AST、ALP、TBIL、DBIL、γ-GT＞ULN


Estimated Enrollment:	2040
Study Start Date:	March 2013
Estimated Study Completion Date:	August 2014
Estimated Primary Completion Date:	August 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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.

Eligibility


Ages Eligible for Study:	18 Years to 75 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01802996

Contacts


Contact: Hua haiqing, MD	0086-025-80864049	huahaiqing@csco.org.cn

Show 27 Study Locations

Sponsors and Collaborators

Cttq

Investigators


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

More Information


Responsible Party:	Cttq
ClinicalTrials.gov Identifier:	NCT01802996 History of Changes
Other Study ID Numbers:	MAGIC-301
Study First Received:	February 26, 2013
Last Updated:	October 29, 2013

Additional relevant MeSH terms:


Wounds and Injuries

ClinicalTrials.gov processed this record on June 23, 2017

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