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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
Sponsor:
Information provided by (Responsible Party):
Cttq

Study Description
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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.

Condition or disease Intervention/treatment Phase
Neoplasms Liver Injury Drug: Magnesium Isoglycyrrhizinate Injection Phase 4

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.

Study Design
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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

Resource links provided by the National Library of Medicine

Drug Information available for: Magnesium

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. The incidence of liver injury [ Time Frame: 0-15 days ]
    anyone of ALT、AST、ALP、TBIL、DBIL、γ-GT＞ULN


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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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


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
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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