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NeoplasmsPhase 4MAGICNCT01802996

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

A Phase 4 study testing Magnesium Isoglycyrrhizinate Injection in people with Neoplasms and Liver Injury, run by Cttq at 27 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Neoplasms, Liver Injury
What is being tested?
Magnesium Isoglycyrrhizinate Injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,040 participants
Where
27 sitesChina
Study dates
Mar 2013to Aug 2014
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • 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.

Trial locations and contacts

27 sites in 1 country.

Hua haiqing, MD contact

0086-025-80864049

huahaiqing@csco.org.cn

27 sites in 1 country

China27 sites, 27 recruiting

  • China PLA General Hospital

    Beijing, Beijing Municipality

    Wang Lijie

    Recruiting

  • The First Affiliated Hospital of General Hospital of PLA ( 304 )

    Beijing, Beijing Municipality

    Ma Junxun

    Recruiting

  • Xiangya Hospital of Central South University

    Changsha, Hunan

    Zhong Meizuo

    Recruiting

  • Changzhou Second People's Hospital

    Changzhou, Jiangsu

    Qian Keqin

    Recruiting

  • Fujian Province-owned Hospital

    Fuzhou, Fujian

    Lin Zhenhe

    Recruiting

  • Fuzhou General Hospital of Nanjing Military Area Command

    Fuzhou, Fujian

    Chen Xi

    Recruiting

  • Guangdong General Hospital

    Guangzhou, Guangdong

    Zheng Dengyun

    Recruiting

  • The First Affiliated Hospital of Guangzhou Medical College

    Guangzhou, Guangdong

    Ouyang Ming

    Recruiting

  • Tumour Hospital Affiliated to Guangzhou Medical College

    Guangzhou, Guangdong

    Chen Wensheng

    Recruiting

  • The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine

    Hefei, Anhui

    Zhou Jinhua

    Recruiting

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi

    Xiong Jianping

    Recruiting

  • The 81st hospital of PLA

    Nanjing, Jiangsu, 210000

    Hua Haiqing, MD, 0086-025-80864049, huahaiqing@csco.org.cn

    Qin Shukui, MD

    Recruiting

  • Nanjing General Hospital of Nanjing Military Area Command

    Nanjing, Jiangsu

    Wang Rui

    Recruiting

  • The First Affiliated Hospital of Nanjing Medical University

    Nanjing, Jiangsu

    Zhu Lingjun

    Recruiting

  • The first hospital of Nanjing

    Nanjing, Jiangsu

    Chen Jinfei

    Recruiting

  • The Second Affiliated Hospital of Nanjing Medical University

    Nanjing, Jiangsu

    Wang Keming

    Recruiting

  • The Affiliated Tumor Hospital of Guangxi Medical University

    Nanning, Guangxi

    Li Yongqiang

    Recruiting

  • The First Affiliated Hospital of Guangxi Medical University

    Nanning, Guangxi

    Lan Dong

    Recruiting

  • Affiliated Hospital of Medical College of Qiingdao University

    Qingdao, Shandong

    Qiu Wensheng

    Recruiting

  • The first hospital of Hebei Medical University

    Shijiazhuang, Hebei

    An Yonghui

    Recruiting

  • The second hospital of Hebei Medical University

    Shijiazhuang, Hebei

    Xie Shaojian

    Recruiting

  • The First Affiliated Hospital of Xinjiang Medical University

    Ürümqi, Xinjiang

    Zhang Hua

    Recruiting

  • The people's Hospital of Wuhan University

    Wuhan, Hubei

    Yao Yi

    Recruiting

  • Wuxi Fourth People's Hospital

    Wuxi, Jiangsu

    Hua Dong

    Recruiting

  • Wuxi People's Hospital

    Wuxi, Jiangsu

    Liu Chaoying

    Recruiting

  • Affiliated Hospital of Xuzhou Medical College

    Xuzhou, Jiangsu

    Xu Haiyang

    Recruiting

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan

    Ma Wang

    Recruiting

Other trials in China

About this study

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

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.

Read the 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.

Being tested
Magnesium Isoglycyrrhizinate Injection
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Magnesium Isoglycyrrhizinate InjectionDrug

    Also called Tianqingganmei®, 2005S07127

    200mg IV on day 1-5

Study groups in NCT01802996
Study groupRoleWhat they receive
Arm IExperimentalMagnesium Isoglycyrrhizinate Injection 200mg IV on days 1-5
Receives: Drug: Magnesium Isoglycyrrhizinate Injection
Arm IINo interventionOnly chemotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The incidence of liver injury

    anyone of ALT、AST、ALP、TBIL、DBIL、γ-GT>ULN

    Measured: 0-15 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Mar 2013 (estimated)
  2. Study startMar 2013
  3. Primary completionAug 2014 (estimated)
  4. Study completionAug 2014 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
2,040 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01802996
Sponsor's protocol ID
MAGIC-301
Acronym
MAGIC
Status last verified
Oct 2013
First submitted
26 Feb 2013
Last updated
30 Oct 2013
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Magnesium Isoglycyrrhizinate Injection in people with Neoplasms and Liver Injury, run by Cttq at 27 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 30 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 27 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Hua haiqing, MD (0086-025-80864049, huahaiqing@csco.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The incidence of liver injury (time frame: 0-15 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01802996.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2013.

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