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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by Cttq
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
  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
Endpoint Classification: Efficacy Study
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:


Further study details as provided by Cttq:

Primary Outcome Measures:
  • The incidence of liver injury [ Time Frame: 0-15 days ] [ Designated as safety issue: No ]
    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
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  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

No publications provided

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
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Neoplasms
Wounds and Injuries

ClinicalTrials.gov processed this record on August 27, 2014