Efficacy and Safety Study of Magnesium Isoglycyrrhizinate Injection in Subjects With Acute Drug-i… (NCT02734966) | Clinical Trial Compass
CompletedPhase 2
Efficacy and Safety Study of Magnesium Isoglycyrrhizinate Injection in Subjects With Acute Drug-induced Liver Injury
China174 participantsStarted 2007-12
Plain-language summary
The purpose of this study is to investigate the safety, effective dosage and treatment of Magnesium Isolycyrrhizinate Injection to cure the acute drug-induced liver injury compared with the Tiopronin Injection.
Who can participate
Age range18 Years – 70 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* RACUM ≥6
* ALTs ≥2ULN, but TBiL is ≤ 3 ULN.It may be associated with AST or ALP or TBiL exceed the upper limit of normal
* Liver biochemical abnormalities duration of no more than three months
* Patients need to fully understand and sign the inform consent form.
Exclusion Criteria:
* The liver injury is caused by other diseases, such as virus hepatitis, alcohol and non-alcohol fatty liver disease or the autoimmune liver disease.
* The patients with the acute hepatic failure or hepatic decompensation, such as hepatic encephalopathy, ascites, albumin is ≤ 35g/L, prothrombin time is elongated more than 2 seconds compared to its normal range.
* The value of the TBiL is \> 3ULN.
* The value of serum creatinine is \> 1.5ULN.
* Patients who have severe organic diseases on heart, lungs, brain, kidney and gastrointestinal tract.
* Patients who are taking the drugs that might interfere the trial.
* Patients who are allergic or intolerant to the study drug.
* Patients who are not able to express the chief complaint, for example, the patients with psychosis and severe neurosis.
* Patients who are compliant with protocol.
* Women who are pregnant, breast-feeding or with childbearing potential.
* Patients who have attended other clinical trials within 3 months.
* Not appropriate to be included after assessing by the investigators.
ULN=Upper Limited Normal
What they're measuring
1
Rate of ALT normalization at week 4 of treatment
Timeframe: 4 weeks
Trial details
NCT IDNCT02734966
SponsorChia Tai Tianqing Pharmaceutical Group Co., Ltd.