Different Cycles of High-dose Dexamethasone for Initial Management of Primary Immune Thrombocytopenia (ITP)
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|ClinicalTrials.gov Identifier: NCT02642380|
Recruitment Status : Withdrawn (No eligible patient was enrolled.)
First Posted : December 30, 2015
Last Update Posted : April 20, 2016
|Condition or disease||Intervention/treatment||Phase|
|Immune Thrombocytopenia||Drug: Dexamethasone (4 cycles) Drug: Dexamethasone (1 cycle)||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Different Cycles of High-dose Dexamethasone for Initial Management of Primary Immune Thrombocytopenia (ITP): a Prospective, Randomized Controlled Trial|
|Study Start Date :||November 2015|
|Estimated Primary Completion Date :||November 2018|
|Estimated Study Completion Date :||November 2018|
Experimental: 4 cycles
Oral administration of dexamethasone 40 mg for four consecutive days every 14 days for 4 courses
Drug: Dexamethasone (4 cycles)
dexamethasone 40mg daily for 4 consecutive days every 14 days for 4 courses
Other Name: DXM 4
Active Comparator: 1 cycle
Oral administration of dexamethasone 40 mg for four consecutive days
Drug: Dexamethasone (1 cycle)
dexamethasone 40mg daily for 4 consecutive days
Other Name: DXM 1
- sustained response to treatment [ Time Frame: 6 months after treatment started ]percentage of patients maintaining PLT count over 30*10^9 without bleeding
- Evaluation of early response [ Time Frame: 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.
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): NCT02642380
|Qilu Hospital, Shandong University|
|Jinan, Shandong, China|
|Principal Investigator:||Ming Hou, MD, PhD||Shandong University, Qilu Hospital|