Glycyrrhetinic Acid Combined With Dexamethasone in Management of Newly Diagnosed ITP

Immune Thrombocytopenia Clinical Trial

Official title:

A Single-center Prospective Randomized Study of Glycyrrhetinic Acid Combined With Dexamethasone in the Treatment of Newly Diagnosed Primary Immune Thrombocytopenia (ITP)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03998982
• Other study ID #: Glycyrrhetinic Acid+DXM in ITP
• Status: Recruiting
• Phase: Phase 4
• Start date: June 25, 2019
• Est. completion date: June 10, 2021

Study information

• Verified date: June 2021
• Source: Shandong University
• Contact: Ming Hou, MD,PhD
• Phone: +86-531-82169114 Ext. 9879
• Email: houming[@]medmail.com.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The project was undertaking by Qilu Hospital of Shandong University in China. In order to report the efficacy and safety of glycyrrhetinic acid combining with high-dose dexamethasone for the treatment of adults with newly-diagnosed primary immune thrombocytopenia (ITP).

Description:

The investigators anticipate to undertaking a parallel group, single-centre, randomised controlled trial of 30 ITP adult patients. One part of the participants are randomly selected to receive glycyrrhetinic acid (given compound glycyrrhizin tablets orally at a dose of 225mg per day for 1 month), combining with dexamethasone (given orally at a dose of 40 mg per day for 4 days, two-cycles with an interval of 10 days); the others are selected to receive high-dose of dexamethasone treatment plus placebo. Platelet count, bleeding and other symptoms were evaluated before and after treatment. Adverse events are also recorded throughout the study. In order to report the efficacy and safety of glycyrrhetinic acid combining with high-dose dexamethasone therapy for the treatment of adults with ITP.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: June 10, 2021
• Est. primary completion date: June 10, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Meet the diagnostic criteria for immune thrombocytopenia;

• Untreated hospitalized patients, may be male or female, between the ages of 18~ 80 years;

• To show a platelet count <30 * 10^9/L, and with bleeding manifestations;

• Willing and able to sign written informed consent

Exclusion Criteria:

• Received chemotherapy or anticoagulants or other drugs affecting the platelet counts within 3 months before the screening visit;

• Received second-line ITP-specific treatments (eg, cyclophosphamide, 6-mercaptopurine, vincristine, vinblastine, etc) within 3 months before the screening visit;

• Received high-dose steroids or IVIG in the 3 weeks prior to the start of the study;

• Current HIV infection;

• Severe medical condition (lung, hepatic or renal disorder) other than chronic ITP. Unstable or uncontrolled disease or condition related to or impacting cardiac

• Female patients who are nursing or pregnant, who may be pregnant, or who contemplate pregnancy during the study period;

• Have a known diagnosis of other autoimmune diseases, established in the medical history and laboratory findings with positive results for the determination of antinuclear antibodies, anti-cardiolipin antibodies, lupus anticoagulant or direct Coombs test;

• Patients who are deemed unsuitable for the study by the investigator.

Related Conditions & MeSH terms

• Immune Thrombocytopenia
• Purpura, Thrombocytopenic, Idiopathic
• Thrombocytopenia

Intervention

Drug:
• Glycyrrhetinic Acid
Compound glycyrrhizin tablets 75 mg three times per day, 1 month
• Dexamethasone
HD-DXM (orally at 40 mg daily for 4d)

Locations

Country	Name	City	State
China	Qilu hospital, Shandong University	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Shandong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sustained response to ITP treatments	Percentage of patients maintaining PLT count over 30*10^9 without bleeding	3 months after treatment started
Secondary	Evaluation of platelet response	Complete response (CR)# A platelet count = 100 * 10^9/L measured on two occasions > 7 days apart and the absence of bleeding. Response (R)# A platelet count = 30 * 10^9/L and a greater than two fold increase in platelet count from baseline measured on two occasions > 7 days apart and the absence of bleeding. No response (NR)# A platelet count < 30 * 10^9/L or a less than two fold increase in platelet count from baseline or the presence of bleeding. Platelet count must be measured on two occasions more than a day apart.	3 months after treatment started