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

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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01802996

Acronym

MAGIC

Enrollment

2040

Registered

2013-03-04

Start date

2013-03-31

Completion date

2014-08-31

Last updated

2013-10-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver Injury, Neoplasms

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.

Interventions

DRUGMagnesium Isoglycyrrhizinate Injection

200mg IV on day 1-5

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
The incidence of liver injury	0-15 days	anyone of ALT、AST、ALP、TBIL、DBIL、γ-GT\>ULN

Countries

China

Contacts

Primary ContactHua haiqing, MD

huahaiqing@csco.org.cn0086-025-80864049

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026