A Multicenter Randomized Open-label Study of Diammonium Glycyrrhizinate Enteric-coated Capsule Plus DXM Versus DXM in Treatment of ITP

• Status: Recruiting
• Trial end date: 2022-07-31
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shandong University
• Treatments: Dexamethasone; Glycyrrhizic Acid

Criteria

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 450 ms for men and greater than 470 ms for women;

• substance misuse within the previous 12 months;

• people who could not adhere to the protocol or were planning to have a surgical procedure in 6 months.