A Multicenter Randomized Open-label Study of Diammonium Glycyrrhizinate Enteric-coated Capsule Pl… (NCT05023915) | Clinical Trial Compass
Active — Not RecruitingPhase 2
A Multicenter Randomized Open-label Study of Diammonium Glycyrrhizinate Enteric-coated Capsule Plus DXM Versus DXM in Treatment of ITP
China106 participantsStarted 2021-08-21
Plain-language summary
The project was undertaking by Qilu Hospital of Shandong University in China. In order to report the efficacy and safety of diammonium glycyrrhizinate enteric-coated capsule plus high-dose dexamethasone for the treatment of adults with newly-diagnosed primary immune thrombocytopenia (ITP).
Who can participate
Age range18 Years – 80 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:
* Meet the diagnostic criteria for immune thrombocytopenia;
* Untreated hospitalized patients or patients from the clinic, may be male or female, between the ages of 18\~ 80 years;
* To show a platelet count \<30 \* 10\^9/L, or with bleeding manifestations, or both;
* Willing and able to sign written informed consent
* ITP patients with hepatitis virus infection or ITP patients with abnormal liver function at the time of enrollment, i.e., ITP patients with indications for diammonium glycyrrhizinate enteric-coated capsule, should be separately stratified.
Exclusion Criteria:
* secondary thrombocytopenia;
* severe immune-deficiency;
* active or previous malignancy;
* HIV virus infection, tuberculosis, or other active infection (sepsis, pneumonia, or abscess);
* pregnancy or lactation;
* diabetes;
* hypertension;
* cardiovascular diseases;
* severe kidney function impairment;
* psychosis;
* osteoporosis;
* inflammatory bowel disease or gastric disease;
* arterial or venous thromboembolism within the 6 months before screening or patients who required anticoagulant treatment;
* an organ or haematopoietic stem-cell transplantation;
* neutrophil count of less than 1500 cells per mm³;
* glycosylated haemoglobin less than 8%;
* partial thromboplastin time 1∙5 times or less the upper limit of normal (ULN); •clinical electrocardiogram changes;
* history of primary immunodeficiency;
* neoplastic disease within the past 5 years;
* corrected QT interval greater than …
What they're measuring
1
14-day initial overall response to ITP treatments
Timeframe: 14 days after treatment started
2
6-month sustained overall response to ITP treatments
Timeframe: A response lasting for at least 6 months without any additional intervention specific to primary immune thrombocytopenia was defined as a sustained response