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A Multicenter Randomized Open-label Study of Diammonium Glycyrrhizinate Enteric-coated Capsule Plus DXM Versus DXM in Treatment of ITP

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ClinicalTrials.gov Identifier: NCT05023915
Recruitment Status : Recruiting
First Posted : August 27, 2021
Last Update Posted : August 27, 2021
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 diammonium glycyrrhizinate enteric-coated capsule plus high-dose dexamethasone for the treatment of adults with newly-diagnosed primary immune thrombocytopenia (ITP).

Condition or disease Intervention/treatment Phase
Immune Thrombocytopenia Drug: dexamethasone Drug: diammonium glycyrrhizinate enteric-coated capsule Phase 2

Detailed Description:
The investigators anticipate to undertaking a parallel group, randomised controlled trial of 106 ITP patients. One part of the participants are randomly selected to receive diammonium glycyrrhizinate enteric-coated capsule orally at a dose of 150mg tid for 3 months), combining with dexamethasone (given orally at a dose of 40 mg qd for 4 days). The others are selected to receive high-dose of dexamethasone alone. Patients who do not respond to the treatment may receive another cycle of high-dose dexamethasone therapy with an interval of 10 days. Platelet count, bleeding and other symptoms were evaluated before and after treatment. Adverse events are also recorded throughout the study. The purpose of this study is to report the efficacy and safety of diammonium glycyrrhizinate enteric-coated capsule combining with high-dose dexamethasone therapy for the treatment of ITP.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 106 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: High-dose Dexamethasone Plus Diammonium Glycyrrhizinate Enteric-coated Capsule Versus High-dose Dexamethasone in Treatment-naive Primary Immune Thrombocytopenia (ITP): a Multicentre, Randomised, Open-label Trial
Estimated Study Start Date : August 21, 2021
Estimated Primary Completion Date : August 21, 2021
Estimated Study Completion Date : July 31, 2022


Arm Intervention/treatment
Active Comparator: diammonium glycyrrhizinate enteric-coated capsule + high-dose dexamethasone
Diammonium glycyrrhizinate enteric-coated capsule orally at a dose of 150mg tid for 3 months, combining with dexamethasone (given orally at a dose of 40 mg qd for 4 days). Patients who do not respond to the treatment may receive another cycle of high-dose dexamethasone therapy with an interval of 10 days.
Drug: dexamethasone
40 mg qd for 4 days

Drug: diammonium glycyrrhizinate enteric-coated capsule
150mg tid for 3 months

Active Comparator: High-dose dexamethasone
Dexamethasone orally at a dose of 40 mg qd for 4 days. Patients who do not respond to the treatment may receive another cycle of high-dose dexamethasone therapy with an interval of 10 days.
Drug: dexamethasone
40 mg qd for 4 days




Primary Outcome Measures :
  1. 14-day initial overall response to ITP treatments [ Time Frame: 14 days after treatment started ]
    Complete response was defined as a platelet count of 100×10⁹ cells per L or higher and an absence of bleeding. Partial response was defined as a platelet count of 30×10⁹ cells per L or higher, but less than 100×10⁹ cells per L, and at least a doubling of the baseline platelet count and an absence of bleeding. Platelet counts were confirmed on two separate occasions at least 7 days apart when defining complete response or partial response. No response was defined as a platelet count of less than 30×10⁹ cells per L, or less than two-times increase from baseline platelet count, or bleeding.

  2. 6-month sustained overall response to ITP treatments [ Time Frame: A response lasting for at least 6 months without any additional intervention specific to primary immune thrombocytopenia was defined as a sustained response ]
    Complete response was defined as a platelet count of 100×10⁹ cells per L or higher and an absence of bleeding. Partial response was defined as a platelet count of 30×10⁹ cells per L or higher, but less than 100×10⁹ cells per L, and at least a doubling of the baseline platelet count and an absence of bleeding. Platelet counts were confirmed on two separate occasions at least 7 days apart when defining complete response or partial response. No response was defined as a platelet count of less than 30×10⁹ cells per L, or less than two-times increase from baseline platelet count, or bleeding.


Secondary Outcome Measures :
  1. time to response [ Time Frame: an average of 6 months ]
    the time from treatment initiation to achieve a complete response or a partial response

  2. duration of response [ Time Frame: through study completion, an average of one year ]
    the time from achievement of a complete response or a partial response to the loss of response (platelet count <30×10⁹ cells per L; measured on two occasions more than 1 day apart or the presence of bleeding).

  3. therapy associated adverse events [ Time Frame: up to one year ]
    nausea and diarrhea (report in frequency); pruritus (report in frequency); headache and dizziness (report in frequency)



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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 or patients from the clinic, may be male or female, between the ages of 18~ 80 years;
  • To show a platelet count <30 * 10^9/L, or with bleeding manifestations, or both;
  • Willing and able to sign written informed consent
  • ITP patients with hepatitis virus infection or ITP patients with abnormal liver function at the time of enrollment, i.e., ITP patients with indications for diammonium glycyrrhizinate enteric-coated capsule, should be separately stratified.

Exclusion Criteria:

  • secondary thrombocytopenia;
  • severe immune-deficiency;
  • active or previous malignancy;
  • HIV virus infection, tuberculosis, or other active infection (sepsis, pneumonia, or abscess);
  • pregnancy or lactation;
  • diabetes;
  • hypertension;
  • cardiovascular diseases;
  • severe kidney function impairment;
  • psychosis;
  • osteoporosis;
  • inflammatory bowel disease or gastric disease;
  • arterial or venous thromboembolism within the 6 months before screening or patients who required anticoagulant treatment;
  • an organ or haematopoietic stem-cell transplantation;
  • neutrophil count of less than 1500 cells per mm³;
  • glycosylated haemoglobin less than 8%;
  • partial thromboplastin time 1∙5 times or less the upper limit of normal (ULN); •clinical electrocardiogram changes;
  • history of primary immunodeficiency;
  • neoplastic disease within the past 5 years;
  • corrected QT interval greater than 450 ms for men and greater than 470 ms for women;
  • substance misuse within the previous 12 months;
  • people who could not adhere to the protocol or were planning to have a surgical procedure in 6 months.

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): NCT05023915


Contacts
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Contact: Ming Hou, MD,PhD +86-531-82169879 qlhouming@sina.com

Locations
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China, Shandong
Qilu hospital, Shandong University Recruiting
Jinan, Shandong, China, 250000
Contact: Ming Hou    +86-531-82169879    qlhouming@sina.com   
Qilu hospital (Qingdao), Shandong University Recruiting
Qingdao, Shandong, China, 266000
Contact: Chenglu Yuan         
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: NCT05023915    
Other Study ID Numbers: ITP-Diammonium Glycyrrhizinate
First Posted: August 27, 2021    Key Record Dates
Last Update Posted: August 27, 2021
Last Verified: August 2021

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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:
Dexamethasone
Diammonium Glycyrrhizinate Enteric-coated Capsule
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
Dexamethasone
Glycyrrhizic 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