Back to resultsGlycyrrhetinic Acid Combined With Dexamethasone in Management of Newly Diagnosed ITP
Primary Purpose
Immune Thrombocytopenia
Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Glycyrrhetinic Acid
Dexamethasone
Sponsored by
About this trial
This is an interventional treatment trial for Immune Thrombocytopenia focused on measuring ITP；glycyrrhetinic acid；dexamethasone
Eligibility Criteria
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.
Sites / Locations
- Qilu hospital, Shandong UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
glycyrrhetinic acid Combining HD-DXM
HD-DXM
Arm Description
Compound glycyrrhizin tablets 75mg three times per day, 1 month, and HD-DXM (orally at 40 mg daily for 4d )
HD-DXM (orally at 40 mg daily for 4d )
Outcomes
Primary Outcome Measures
Sustained response to ITP treatments
Percentage of patients maintaining PLT count over 30*10^9 without bleeding
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03998982
Brief Title
Glycyrrhetinic Acid Combined With Dexamethasone in Management of Newly Diagnosed ITP
Official Title
A Single-center Prospective Randomized Study of Glycyrrhetinic Acid Combined With Dexamethasone in the Treatment of Newly Diagnosed Primary Immune Thrombocytopenia (ITP)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Unknown status
Study Start Date
June 25, 2019 (Actual)
Primary Completion Date
June 10, 2021 (Anticipated)
Study Completion Date
June 10, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shandong University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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).
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Immune Thrombocytopenia
Keywords
ITP；glycyrrhetinic acid；dexamethasone
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
glycyrrhetinic acid Combining HD-DXM
Arm Type
Active Comparator
Arm Description
Compound glycyrrhizin tablets 75mg three times per day, 1 month, and HD-DXM (orally at 40 mg daily for 4d )
Arm Title
HD-DXM
Arm Type
Active Comparator
Arm Description
HD-DXM (orally at 40 mg daily for 4d )
Intervention Type
Drug
Intervention Name(s)
Glycyrrhetinic Acid
Intervention Description
Compound glycyrrhizin tablets 75 mg three times per day, 1 month
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
HD-DXM (orally at 40 mg daily for 4d)
Primary Outcome Measure Information:
Title
Sustained response to ITP treatments
Description
Percentage of patients maintaining PLT count over 30*10^9 without bleeding
Time Frame
3 months after treatment started
Secondary Outcome Measure Information:
Title
Evaluation of platelet response
Description
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.
Time Frame
3 months after treatment started
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ming Hou, MD,PhD
Phone
+86-531-82169114 Ext. 9879
Email
houming@medmail.com.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ming Hou, MD,PhD
Organizational Affiliation
Shandong University Qilu Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Qilu hospital, Shandong University
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250012
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ming Hou
Email
houming@medmail.com.cn
First Name & Middle Initial & Last Name & Degree
Ming Hou
12. IPD Sharing Statement
Learn more about this trial
Glycyrrhetinic Acid Combined With Dexamethasone in Management of Newly Diagnosed ITP
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