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

Phase 2

• Conditions: Immune Thrombocytopenia
• Interventions: Drug: dexamethasone; Drug: diammonium glycyrrhizinate enteric-coated capsule

• Registration Number: NCT05023915
• Lead Sponsor: Shandong University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2021-08
• Study Start: 2021-08-21
• Primary Completion: 2021-08-21
• Study First Submitted: 2021-08-21
• Study First Submitted QC: 2021-08-21
• Last Update Submitted: 2021-08-21
• Study First Posted: 2021-08-27
• Last Update Posted: 2021-08-27
• Study Completion: 2022-07-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 106

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
diammonium glycyrrhizinate enteric-coated capsule + high-dose dexamethasone	diammonium glycyrrhizinate enteric-coated capsule	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). Patients who do not respond to the treatment may receive another cycle of high-dose dexamethasone therapy with an interval of 10 days.
High-dose dexamethasone	dexamethasone	Dexamethasone orally at a dose of 40 mg qd for 4 days. Patients who do not respond to the treatment may receive another cycle of high-dose dexamethasone therapy with an interval of 10 days.
diammonium glycyrrhizinate enteric-coated capsule + high-dose dexamethasone	dexamethasone	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). Patients who do not respond to the treatment may receive another cycle of high-dose dexamethasone therapy with an interval of 10 days.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
therapy associated adverse events	up to one year	nausea and diarrhea (report in frequency); pruritus (report in frequency); headache and dizziness (report in frequency)
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).

Trial Locations

Locations (2)

Qilu hospital (Qingdao), Shandong University; 🇨🇳 Qingdao, Shandong, China

Qilu hospital, Shandong University; 🇨🇳 Jinan, Shandong, China