ClinicalTrials.Veeva

Menu

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

C

CTTQ

Status and phase

Unknown
Phase 4

Conditions

Liver Injury
Neoplasms

Treatments

Drug: Magnesium Isoglycyrrhizinate Injection

Study type

Interventional

Funder types

Industry

Identifiers

NCT01802996
MAGIC-301

Details and patient eligibility

About

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.

Full 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.

Enrollment

2,040 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No 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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

2,040 participants in 2 patient groups

Arm I
Experimental group
Description:
Magnesium Isoglycyrrhizinate Injection 200mg IV on days 1-5
Treatment:
Drug: Magnesium Isoglycyrrhizinate Injection
Arm II
No Intervention group
Description:
Only chemotherapy

Trial contacts and locations

27

Loading...

Central trial contact

Hua haiqing, MD

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems