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

  • STATUS
    Recruiting
  • days left to enroll
    33
  • participants needed
    106
  • sponsor
    Shandong University
Updated on 3 September 2021
platelet count
thrombocytopenia
dexamethasone

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).

Description

The investigators anticipate to undertaking a parallel group, randomised controlled trial of 106 ITP patients. One part of the participants are randomly selected to receive diammonium glycyrrhizinate enteric-coated capsule orally at a dose of 150mg tid for 3 months), combining with dexamethasone (given orally at a dose of 40 mg qd for 4 days). The others are selected to receive high-dose of dexamethasone alone. Patients who do not respond to the treatment may receive another cycle of high-dose dexamethasone therapy with an interval of 10 days. Platelet count, bleeding and other symptoms were evaluated before and after treatment. Adverse events are also recorded throughout the study. The purpose of this study is to report the efficacy and safety of diammonium glycyrrhizinate enteric-coated capsule combining with high-dose dexamethasone therapy for the treatment of ITP.

Details
Condition IDIOPATHIC THROMBOCYTOPENIC PURPURA, Immune Thrombocytopenia, Autoimmune Disease, Idiopathic Thrombocytopenic Purpura (ITP), Autoimmune disease, autoimmune thrombocytopenia, Thrombocytopenic
Treatment Dexamethasone, diammonium glycyrrhizinate enteric-coated capsule
Clinical Study IdentifierNCT05023915
SponsorShandong University
Last Modified on3 September 2021

Eligibility

Yes No Not Sure

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 mm
glycosylated haemoglobin less than 8%
partial thromboplastin time 15 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
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