Immune Thrombocytopenia
Conditions
Keywords
Dexamethasone, Diammonium Glycyrrhizinate Enteric-coated Capsule
Brief 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).
Detailed 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 1 month), 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.
Interventions
DRUGdexamethasone
40 mg qd for 4 days
DRUGdiammonium glycyrrhizinate enteric-coated capsule
150mg tid for 1 month
Sponsors
Shandong University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 14-day initial overall response to ITP treatments | 14 days after treatment started | Complete response was defined as a platelet count of 100×10⁹ cells per L or higher and an absence of bleeding. Partial response was defined as a platelet count of 30×10⁹ cells per L or higher, but less than 100×10⁹ cells per L, and at least a doubling of the baseline platelet count and an absence of bleeding. Platelet counts were confirmed on two separate occasions at least 7 days apart when defining complete response or partial response. No response was defined as a platelet count of less than 30×10⁹ cells per L, or less than two-times increase from baseline platelet count, or bleeding. |
| 6-month sustained overall response to ITP treatments | A response lasting for at least 6 months without any additional intervention specific to primary immune thrombocytopenia was defined as a sustained response | Complete response was defined as a platelet count of 100×10⁹ cells per L or higher and an absence of bleeding. Partial response was defined as a platelet count of 30×10⁹ cells per L or higher, but less than 100×10⁹ cells per L, and at least a doubling of the baseline platelet count and an absence of bleeding. Platelet counts were confirmed on two separate occasions at least 7 days apart when defining complete response or partial response. No response was defined as a platelet count of less than 30×10⁹ cells per L, or less than two-times increase from baseline platelet count, or bleeding. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| time to response | an average of 6 months | the time from treatment initiation to achieve a complete response or a partial response |
| duration of response | through study completion, an average of one year | the time from achievement of a complete response or a partial response to the loss of response (platelet count \<30×10⁹ cells per L; measured on two occasions more than 1 day apart or the presence of bleeding). |
| therapy associated adverse events | up to one year | nausea and diarrhea (report in frequency); pruritus (report in frequency); headache and dizziness (report in frequency) |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORMing Hou, MD,PhD
Shandong University Qilu Hospital
Outcome results
None listed