Evaluate the Efficacy of Magnesium Isoglycyrrhizinate in the Prevention of Chemotherapy Related Acute Liver Injury (MAGIC)
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ClinicalTrials.gov Identifier: NCT01802996 |
Recruitment Status
: Unknown
Verified October 2013 by Cttq.
Recruitment status was: Recruiting
First Posted
: March 4, 2013
Last Update Posted
: October 30, 2013
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Condition or disease | Intervention/treatment | Phase |
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Neoplasms Liver Injury | Drug: Magnesium Isoglycyrrhizinate Injection | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Estimated 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 : | March 2013 |
Estimated Primary Completion Date : | August 2014 |
Estimated Study Completion Date : | August 2014 |

Arm | Intervention/treatment |
---|---|
Experimental: Arm I
Magnesium Isoglycyrrhizinate Injection 200mg IV on days 1-5
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Drug: Magnesium Isoglycyrrhizinate Injection
200mg IV on day 1-5
Other Names:
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No Intervention: Arm II
Only chemotherapy
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- The incidence of liver injury [ Time Frame: 0-15 days ]anyone of ALT、AST、ALP、TBIL、DBIL、γ-GT>ULN

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01802996
Contact: Hua haiqing, MD | 0086-025-80864049 | huahaiqing@csco.org.cn |

Principal Investigator: | Qin Shukui, MD | The 81st hospital of PLA |
Responsible Party: | Cttq |
ClinicalTrials.gov Identifier: | NCT01802996 History of Changes |
Other Study ID Numbers: |
MAGIC-301 |
First Posted: | March 4, 2013 Key Record Dates |
Last Update Posted: | October 30, 2013 |
Last Verified: | October 2013 |
Additional relevant MeSH terms:
Wounds and Injuries |