Status:
UNKNOWN
Evaluate the Efficacy of Magnesium Isoglycyrrhizinate in the Prevention of Chemotherapy Related Acute Liver Injury
Lead Sponsor:
Cttq
Conditions:
Neoplasms
Liver Injury
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2014
Estimated Enrollment :
2040 Patients enrolled
Trial Details
Trial ID
NCT01802996
Start Date
March 1 2013
End Date
August 1 2014
Last Update
October 30 2013
Active Locations (27)
Enter a location and click search to find clinical trials sorted by distance.
1
The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine
Hefei, Anhui, China
2
China PLA General Hospital
Beijing, Beijing Municipality, China
3
The First Affiliated Hospital of General Hospital of PLA ( 304 )
Beijing, Beijing Municipality, China
4
Fujian Province-owned Hospital
Fuzhou, Fujian, China