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

NCT05023915 | Active Not Recruiting Phase 2

• 1 other identifier: ITP-Diammonium Glycyrrhizinate
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 2

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).

Conditions

Immune Thrombocytopenia

Keywords

Dexamethasone; Diammonium Glycyrrhizinate Enteric-coated Capsule

Outcome Measures

Primary Outcomes (2)

• 14-day initial overall response to ITP treatments

  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.

  14 days after treatment started

• 6-month sustained overall response to ITP treatments

  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.

  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 (3)

• time to response

  an average of 6 months

• duration of response

  through study completion, an average of one year

• therapy associated adverse events

  up to one year

Study Arms (2)

diammonium glycyrrhizinate enteric-coated capsule + high-dose dexamethasone

ACTIVE COMPARATOR

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). Patients who do not respond to the treatment may receive another cycle of high-dose dexamethasone therapy with an interval of 10 days.

Drug: dexamethasone; Drug: diammonium glycyrrhizinate enteric-coated capsule

High-dose dexamethasone

ACTIVE COMPARATOR

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.

Drug: dexamethasone

Interventions

dexamethasone DRUG

40 mg qd for 4 days

High-dose dexamethasone; diammonium glycyrrhizinate enteric-coated capsule + high-dose dexamethasone

diammonium glycyrrhizinate enteric-coated capsule DRUG

150mg tid for 1 month

diammonium glycyrrhizinate enteric-coated capsule + high-dose dexamethasone

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Shandong University: lead

Study Sites (2)

Qilu hospital, Shandong University

Jinan, Shandong, 250000, China

Location

Qilu hospital (Qingdao), Shandong University

Qingdao, Shandong, 266000, China

Location

MeSH Terms

Conditions

Purpura, Thrombocytopenic, Idiopathic

Interventions

Dexamethasone

Condition Hierarchy (Ancestors)

Purpura, Thrombocytopenic; Purpura; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Thrombotic Microangiopathies; Thrombocytopenia; Blood Platelet Disorders; Cytopenia; Hemorrhagic Disorders; Autoimmune Diseases; Immune System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Ming Hou, MD,PhD

  Shandong University Qilu Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Director

Study Record Dates

• First Submitted: August 21, 2021
• First Posted: August 27, 2021
• Study Start: August 21, 2021
• Primary Completion: August 21, 2021
• Study Completion: January 31, 2026
• Last Updated: January 26, 2026

Record last verified: 2026-01

Locations

CN (2)