Clinical trial · Interventional
Evaluate the Efficacy of Magnesium Isoglycyrrhizinate in the Prevention of Chemotherapy Related Acute Liver Injury
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
NCT01802996CI-TRIAL-00012495MAGICunknownPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Liver Injury | — | UNRESOLVED | — |
| Neoplasms | Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Magnesium Isoglycyrrhizinate Injection | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- Magnesium Isoglycyrrhizinate Injection 200mg IV on days 1-5
- interventionNames
- Drug: Magnesium Isoglycyrrhizinate Injection
- type
- NO_INTERVENTION
- label
- Arm II
- description
- Only chemotherapy
Primary outcomes (1)
- measure
- The incidence of liver injury
- timeFrame
- 0-15 days
- description
- anyone of ALT、AST、ALP、TBIL、DBIL、γ-GT\>ULN
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.