Last updated: August 21, 2021
Sponsor: Shandong University
Overall Status: Active - Recruiting
Phase
2
Condition
Immune (Idiopathic) Thrombocytopenic Purpura (Itp)
Thrombosis
Thrombocytopenia And Thrombocytopenia Prevention
Treatment
N/AClinical Study ID
NCT05023915
ITP-Diammonium Glycyrrhizinate
Ages 18-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 liverfunction at the time of enrollment, i.e., ITP patients with indications for diammoniumglycyrrhizinate enteric-coated capsule, should be separately stratified.
Exclusion
Exclusion Criteria:
- secondary thrombocytopenia;
- severe immune-deficiency;
- active or previous malignancy;
- HIV virus infection, tuberculosis, or other active infection (sepsis, pneumonia, orabscess);
- 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 patientswho 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 surgicalprocedure in 6 months.
Study Design
Total Participants: 106
Study Start date:
August 21, 2021
Estimated Completion Date:
July 31, 2022
Study Description
Connect with a study center
Qilu hospital, Shandong University
Jinan, Shandong 250000
ChinaActive - Recruiting
Qilu hospital (Qingdao), Shandong University
Qingdao, Shandong 266000
ChinaActive - Recruiting
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