An Investigation of Dexamethasone With Different Doses in the Management of Immune Thrombocytopenia (ITP)
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|ClinicalTrials.gov Identifier: NCT02153060|
Recruitment Status : Completed
First Posted : June 2, 2014
Last Update Posted : April 20, 2016
|Condition or disease||Intervention/treatment||Phase|
|Immune Thrombocytopenia||Drug: Dexamethasone||Phase 2|
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).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||58 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multi-center, Randomized, Open-label Study to Evaluate the Efficacy and Safety of Different Doses of Dexamethasone for Management of Immune Thrombocytopenia (ITP)|
|Study Start Date :||May 2014|
|Actual Primary Completion Date :||January 2015|
|Actual Study Completion Date :||August 2015|
Experimental: 20mg dexamethasone group
Dexamethasone 20 mg per day, 4 consecutive days
Dexamethasone was given at a dose of 20 mg,daily for 4 consecutive days
Experimental: 40mg dexamethasone group
Dexamethasone 40 mg per day, 4 consecutive days
Dexamethasone was given at a dose of 40 mg,daily for 4 consecutive days
- Proposed criteria for assessing early response to ITP treatments [ Time Frame: 3 months ]
- 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.
- Safety [ Time Frame: 1 years ]The type and frequency of therapy associated adverse events
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): NCT02153060
|Qilu Hospital, Shandong University|
|Jinan, Shandong, China, 250012|
|Principal Investigator:||Ming Hou, DR.||Shandong University|