- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03998982
Glycyrrhetinic Acid Combined With Dexamethasone in Management of Newly Diagnosed ITP
June 10, 2021 updated by: Ming Hou, Shandong University
A Single-center Prospective Randomized Study of Glycyrrhetinic Acid Combined With Dexamethasone in the Treatment of Newly Diagnosed Primary Immune Thrombocytopenia (ITP)
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).
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
30
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Ming Hou, MD,PhD
- Phone Number: +86-531-82169114 Ext. 9879
- Email: houming@medmail.com.cn
Study Locations
-
-
Shandong
-
Jinan, Shandong, China, 250012
- Recruiting
- Qilu Hospital, Shandong University
-
Principal Investigator:
- Ming Hou
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 78 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: HD-DXM
HD-DXM (orally at 40 mg daily for 4d )
|
HD-DXM (orally at 40 mg daily for 4d)
|
Active Comparator: glycyrrhetinic acid Combining HD-DXM
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)
Compound glycyrrhizin tablets 75 mg three times per day, 1 month
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sustained response to ITP treatments
Time Frame: 3 months after treatment started
|
Percentage of patients maintaining PLT count over 30*10^9 without bleeding
|
3 months after treatment started
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluation of platelet response
Time Frame: 3 months after treatment started
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 25, 2019
Primary Completion (Anticipated)
June 10, 2021
Study Completion (Anticipated)
June 10, 2021
Study Registration Dates
First Submitted
June 25, 2019
First Submitted That Met QC Criteria
June 25, 2019
First Posted (Actual)
June 26, 2019
Study Record Updates
Last Update Posted (Actual)
June 11, 2021
Last Update Submitted That Met QC Criteria
June 10, 2021
Last Verified
June 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Immune System Diseases
- Autoimmune Diseases
- Hematologic Diseases
- Hemorrhage
- Hemorrhagic Disorders
- Blood Coagulation Disorders
- Skin Manifestations
- Blood Platelet Disorders
- Thrombotic Microangiopathies
- Purpura, Thrombocytopenic
- Purpura
- Purpura, Thrombocytopenic, Idiopathic
- Thrombocytopenia
- Physiological Effects of Drugs
- Autonomic Agents
- Peripheral Nervous System Agents
- Anti-Inflammatory Agents
- Antineoplastic Agents
- Antiemetics
- Gastrointestinal Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Dexamethasone
- Glycyrrhetinic Acid
Other Study ID Numbers
- Glycyrrhetinic Acid+DXM in ITP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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