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出境医 / 临床实验 / Glycyrrhetinic Acid Combined With Dexamethasone in Management of Newly Diagnosed ITP

Glycyrrhetinic Acid Combined With Dexamethasone in Management of Newly Diagnosed ITP

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).

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.
Study Design
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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
Arms and Interventions
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)
Outcome Measures
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.


Eligibility Criteria
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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.
Contacts and Locations

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
Layout table for investigator information
Principal Investigator: Ming Hou, MD,PhD Shandong University, Qilu Hospital
Tracking Information
First Submitted Date  ICMJE June 25, 2019
First Posted Date  ICMJE June 26, 2019
Last Update Posted Date March 23, 2020
Actual Study Start Date  ICMJE June 25, 2019
Estimated Primary Completion Date April 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 25, 2019) 		Sustained response to ITP treatments [ Time Frame: 3 months after treatment started ]
Percentage of patients maintaining PLT count over 30*10^9 without bleeding
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 25, 2019) 		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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Glycyrrhetinic Acid Combined With Dexamethasone in Management of Newly Diagnosed ITP
Official Title  ICMJE A Single-center Prospective Randomized Study of Glycyrrhetinic Acid Combined With Dexamethasone in the Treatment of Newly Diagnosed Primary Immune Thrombocytopenia (ITP)
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Immune Thrombocytopenia
Intervention  ICMJE
  • 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)
Study Arms  ICMJE
  • 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 )
    Interventions:
    • Drug: Glycyrrhetinic Acid
    • Drug: Dexamethasone
  • Active Comparator: HD-DXM
    HD-DXM (orally at 40 mg daily for 4d )
    Intervention: Drug: Dexamethasone
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 25, 2019) 		30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 1, 2020
Estimated Primary Completion Date April 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Ming Hou, MD,PhD +86-531-82169114 Ext. 9879 houming@medmail.com.cn
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03998982
Other Study ID Numbers  ICMJE Glycyrrhetinic Acid+DXM in ITP
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ming Hou, Shandong University
Study Sponsor  ICMJE Shandong University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ming Hou, MD,PhD Shandong University, Qilu Hospital
PRS Account Shandong University
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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