Clinical trial NCT05023915: A Multicenter Randomized Open-label Study of Diammonium Glycyrrhizinate Enteric-coated Capsule Plus DXM Versus DXM in Treatment of ITP
Official title: High-dose Dexamethasone Plus Diammonium Glycyrrhizinate Enteric-coated Capsule Versus High-dose Dexamethasone in Treatment-naive Primary Immune Thrombocytopenia (ITP): a Multicentre, Randomised, Open-label Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Immune Thrombocytopenia
Keywords: Dexamethasone
Diammonium Glycyrrhizinate Enteric-coated Capsule
Lead sponsor: Shandong University
Sponsor class: OTHER
First posted: 2021-08-27
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

Eligibility 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.

Primary outcomes:
measure: 14-day initial overall response to ITP treatments
timeFrame: 14 days after treatment started
measure: 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
Secondary outcomes:
measure: time to response
timeFrame: an average of 6 months
measure: duration of response
timeFrame: through study completion, an average of one year
measure: therapy associated adverse events
timeFrame: up to one year
Other outcomes:
Locations:
city: Jinan
country: China
facility: Qilu hospital, Shandong University
state: Shandong
city: Qingdao
country: China
facility: Qilu hospital (Qingdao), Shandong University
state: Shandong
Study officials:
affiliation: Shandong University Qilu Hospital
name: Ming Hou, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: