Back to resultsA Multicenter Randomized Open-label Study of Diammonium Glycyrrhizinate Enteric-coated Capsule Plus DXM Versus DXM in Treatment of ITP
Primary Purpose
Immune Thrombocytopenia
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
dexamethasone
diammonium glycyrrhizinate enteric-coated capsule
Sponsored by
About this trial
This is an interventional treatment trial for Immune Thrombocytopenia focused on measuring Dexamethasone, Diammonium Glycyrrhizinate Enteric-coated Capsule
Eligibility 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.
Sites / Locations
- Qilu hospital, Shandong UniversityRecruiting
- Qilu hospital (Qingdao), Shandong UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
diammonium glycyrrhizinate enteric-coated capsule + high-dose dexamethasone
High-dose dexamethasone
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
14-day initial overall response to ITP treatments
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.
6-month sustained overall response to ITP treatments
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
time to response
the time from treatment initiation to achieve a complete response or a partial response
duration of response
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).
therapy associated adverse events
nausea and diarrhea (report in frequency); pruritus (report in frequency); headache and dizziness (report in frequency)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05023915
Brief Title
A Multicenter Randomized Open-label Study of Diammonium Glycyrrhizinate Enteric-coated Capsule Plus DXM Versus DXM in Treatment of ITP
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 21, 2021 (Anticipated)
Primary Completion Date
August 21, 2021 (Anticipated)
Study Completion Date
July 31, 2022 (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 diammonium glycyrrhizinate enteric-coated capsule plus 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, 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Immune Thrombocytopenia
Keywords
Dexamethasone, Diammonium Glycyrrhizinate Enteric-coated Capsule
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
106 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
diammonium glycyrrhizinate enteric-coated capsule + high-dose dexamethasone
Arm Type
Active Comparator
Arm Description
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.
Arm Title
High-dose dexamethasone
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
dexamethasone
Intervention Description
40 mg qd for 4 days
Intervention Type
Drug
Intervention Name(s)
diammonium glycyrrhizinate enteric-coated capsule
Intervention Description
150mg tid for 3 months
Primary Outcome Measure Information:
Title
14-day initial overall response to ITP treatments
Description
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.
Time Frame
14 days after treatment started
Title
6-month sustained overall response to ITP treatments
Description
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.
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
Secondary Outcome Measure Information:
Title
time to response
Description
the time from treatment initiation to achieve a complete response or a partial response
Time Frame
an average of 6 months
Title
duration of response
Description
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).
Time Frame
through study completion, an average of one year
Title
therapy associated adverse events
Description
nausea and diarrhea (report in frequency); pruritus (report in frequency); headache and dizziness (report in frequency)
Time Frame
up to one year
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 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ming Hou, MD,PhD
Phone
+86-531-82169879
Email
qlhouming@sina.com
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
250000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ming Hou
Phone
+86-531-82169879
Email
qlhouming@sina.com
Facility Name
Qilu hospital (Qingdao), Shandong University
City
Qingdao
State/Province
Shandong
ZIP/Postal Code
266000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chenglu Yuan
12. IPD Sharing Statement
Learn more about this trial
A Multicenter Randomized Open-label Study of Diammonium Glycyrrhizinate Enteric-coated Capsule Plus DXM Versus DXM in Treatment of ITP
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