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Glycyrrhetinic Acid Combined With Dexamethasone in Management of Newly Diagnosed ITP

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03998982
Recruitment Status : Recruiting
First Posted : June 26, 2019
Last Update Posted : March 23, 2020
Sponsor:
Information provided by (Responsible Party):
Ming Hou, 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 glycyrrhetinic acid combining with high-dose dexamethasone for the treatment of adults with newly-diagnosed primary immune thrombocytopenia (ITP).

Condition or disease Intervention/treatment Phase
Immune Thrombocytopenia Drug: Glycyrrhetinic Acid Drug: Dexamethasone Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Single-center Prospective Randomized Study of Glycyrrhetinic Acid Combined With Dexamethasone in the Treatment of Newly Diagnosed Primary Immune Thrombocytopenia (ITP)
Actual Study Start Date : June 25, 2019
Estimated Primary Completion Date : April 1, 2020
Estimated Study Completion Date : April 1, 2020


Arm Intervention/treatment
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 )
Drug: Glycyrrhetinic Acid
Compound glycyrrhizin tablets 75 mg three times per day, 1 month

Drug: Dexamethasone
HD-DXM (orally at 40 mg daily for 4d)

Active Comparator: HD-DXM
HD-DXM (orally at 40 mg daily for 4d )
Drug: Dexamethasone
HD-DXM (orally at 40 mg daily for 4d)




Primary Outcome Measures :
  1. Sustained response to ITP treatments [ Time Frame: 3 months after treatment started ]
    Percentage of patients maintaining PLT count over 30*10^9 without bleeding


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03998982


Contacts
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Contact: Ming Hou, MD,PhD +86-531-82169114 Ext. 9879 houming@medmail.com.cn

Locations
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China, Shandong
Qilu hospital, Shandong University Recruiting
Jinan, Shandong, China, 250012
Contact: Ming Hou       houming@medmail.com.cn   
Principal Investigator: Ming Hou         
Sponsors and Collaborators
Shandong University
Investigators
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Principal Investigator: Ming Hou, MD,PhD Shandong University, Qilu Hospital
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Responsible Party: Ming Hou, Professor and Director, Shandong University
ClinicalTrials.gov Identifier: NCT03998982    
Other Study ID Numbers: Glycyrrhetinic Acid+DXM in ITP
First Posted: June 26, 2019    Key Record Dates
Last Update Posted: March 23, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ming Hou, Shandong University:
ITP;glycyrrhetinic acid;dexamethasone
Additional relevant MeSH terms:
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Thrombocytopenia
Immune System Diseases
Purpura, Thrombocytopenic, Idiopathic
Blood Platelet Disorders
Hematologic Diseases
Purpura, Thrombocytopenic
Purpura
Blood Coagulation Disorders
Thrombotic Microangiopathies
Hemorrhagic Disorders
Autoimmune Diseases
Hemorrhage
Pathologic Processes
Skin Manifestations
Signs and Symptoms
Dexamethasone
Glycyrrhetinic Acid
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents