Back to resultsDifferent Cycles of High-dose Dexamethasone for Initial Management of Primary Immune Thrombocytopenia (ITP)
Primary Purpose
Immune Thrombocytopenia
Status
Withdrawn
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Dexamethasone (4 cycles)
Dexamethasone (1 cycle)
Sponsored by
About this trial
This is an interventional treatment trial for Immune Thrombocytopenia focused on measuring ITP, high-dose dexamethasone
Eligibility 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 or hepatitis B virus or hepatitis C virus infections.
- Severe medical condition (lung, hepatic or renal disorder) other than chronic ITP. Unstable or uncontrolled disease or condition related to or impacting cardiac function (e.g., unstable angina, congestive heart failure, uncontrolled hypertension or cardiac arrhythmia)
- 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.
Sites / Locations
- Qilu Hospital, Shandong University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
4 cycles
1 cycle
Arm Description
Oral administration of dexamethasone 40 mg for four consecutive days every 14 days for 4 courses
Oral administration of dexamethasone 40 mg for four consecutive days
Outcomes
Primary Outcome Measures
sustained response to treatment
percentage of patients maintaining PLT count over 30*10^9 without bleeding
Secondary Outcome Measures
Evaluation of early response
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02642380
Brief Title
Different Cycles of High-dose Dexamethasone for Initial Management of Primary Immune Thrombocytopenia (ITP)
Official Title
Different Cycles of High-dose Dexamethasone for Initial Management of Primary Immune Thrombocytopenia (ITP): a Prospective, Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Withdrawn
Why Stopped
No eligible patient was enrolled.
Study Start Date
November 2015 (undefined)
Primary Completion Date
November 2018 (Anticipated)
Study Completion Date
November 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shandong University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The project was organized by Qilu Hospital of Shandong University in China. In order to report the efficacy and safety of different cycles of high-dose dexamethasone for the treatment of adults with newly-diagnosed primary immune thrombocytopenia (ITP).
Detailed Description
The investigators are undertaking a multicenter, randomized, controlled trial of 200 primary ITP adult patients from 11 medical centers in China. One part of the participants are randomly selected to receive four cycles of high-dose dexamethasone (given orally at a dose of 40mg per day for 4 consecutive days every 14 days for 4 cycles), comparing the others with one cycle (given orally at a dose of 40 mg per day for 4 consecutive days).
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 different cycles of high-dose dexamethasone therapy for the treatment of adults with ITP.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Immune Thrombocytopenia
Keywords
ITP, high-dose dexamethasone
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
4 cycles
Arm Type
Experimental
Arm Description
Oral administration of dexamethasone 40 mg for four consecutive days every 14 days for 4 courses
Arm Title
1 cycle
Arm Type
Active Comparator
Arm Description
Oral administration of dexamethasone 40 mg for four consecutive days
Intervention Type
Drug
Intervention Name(s)
Dexamethasone (4 cycles)
Other Intervention Name(s)
DXM 4
Intervention Description
dexamethasone 40mg daily for 4 consecutive days every 14 days for 4 courses
Intervention Type
Drug
Intervention Name(s)
Dexamethasone (1 cycle)
Other Intervention Name(s)
DXM 1
Intervention Description
dexamethasone 40mg daily for 4 consecutive days
Primary Outcome Measure Information:
Title
sustained response to treatment
Description
percentage of patients maintaining PLT count over 30*10^9 without bleeding
Time Frame
6 months after treatment started
Secondary Outcome Measure Information:
Title
Evaluation of early response
Description
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.
Time Frame
2 months after treatment started
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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 or hepatitis B virus or hepatitis C virus infections.
Severe medical condition (lung, hepatic or renal disorder) other than chronic ITP. Unstable or uncontrolled disease or condition related to or impacting cardiac function (e.g., unstable angina, congestive heart failure, uncontrolled hypertension or cardiac arrhythmia)
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.
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
Country
China
12. IPD Sharing Statement
Learn more about this trial
Different Cycles of High-dose Dexamethasone for Initial Management of Primary Immune Thrombocytopenia (ITP)
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