A Multi-center, Randomized, Open-label Study to Evaluate the Efficacy and Safety of Different Doses of Dexamethasone for Management of Immune Thrombocytopenia (ITP)
Overview
- Phase
- Phase 2
- Intervention
- Dexamethasone
- Conditions
- Immune Thrombocytopenia
- Sponsor
- Shandong University
- Enrollment
- 58
- Locations
- 1
- Primary Endpoint
- Proposed criteria for assessing early response to ITP treatments
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
The project was undertaking by Qilu Hospital of Shandong University and other 7 well-known hospitals in China. In order to report the efficacy and safety of different dose dexamethasone in treating the immune thrombocytopenia (ITP).
Detailed Description
The investigators are undertaking a parallel group, multicentre, randomised controlled trial of 60 adults with ITP from 7 medical centers in China. Part of the participants are randomly selected to receive dexamethasone (given at a dose of 40mg per day for 4 consecutive days) ,the others are selected to receive dexamethasone(given at a dose of 20 mg daily for 4 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 dose dexamethasone for the treatment of adults with immune thrombocytopenia (ITP).
Investigators
Ming Hou
Professor and Director
Shandong University
Eligibility Criteria
Inclusion Criteria
- •Meet the diagnostic criteria for immune thrombocytopenia
- •Untreated hospitalized patients, may be male or female, between the ages of 18 \~ 75 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
Arms & Interventions
20mg dexamethasone group
Dexamethasone 20 mg per day, 4 consecutive days
Intervention: Dexamethasone
40mg dexamethasone group
Dexamethasone 40 mg per day, 4 consecutive days
Intervention: Dexamethasone
Outcomes
Primary Outcomes
Proposed criteria for assessing early response to ITP treatments
Time Frame: 3 months
1. Complete response (CR)： A platelet count ≥ 100 \* 10\^9/L measured on two occasions \> 7 days apart and the absence of bleeding. 2. 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. 3. 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.
Secondary Outcomes
- Safety(1 years)