Different Cycles of High-dose Dexamethasone for Initial Management of Primary Immune Thrombocytopenia (ITP)
- Conditions
- Immune Thrombocytopenia
- Interventions
- Registration Number
- NCT02642380
- Lead Sponsor
- Shandong University
- 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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 cycle Dexamethasone (1 cycle) Oral administration of dexamethasone 40 mg for four consecutive days 4 cycles Dexamethasone (4 cycles) Oral administration of dexamethasone 40 mg for four consecutive days every 14 days for 4 courses
- Primary Outcome Measures
Name Time Method sustained response to treatment 6 months after treatment started percentage of patients maintaining PLT count over 30\*10\^9 without bleeding
- Secondary Outcome Measures
Name Time Method Evaluation of early response 2 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.
Trial Locations
- Locations (1)
Qilu Hospital, Shandong University
🇨🇳Jinan, Shandong, China