A Phase 2 interventional study of Dexamethasone and Dexamethasone in Immune Thrombocytopenia, sponsored by Shandong University. Completed at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2016-04-20.
Sponsored by Shandong University · Phase 2, Interventional, and Treatment
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).
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).
697 studies on the registry are indexed under Thrombocytopenia; 153 are open to participants now.
This study's enrollment of 58 is close to the median of 55 across 472 interventional studies indexed under Thrombocytopenia.
Browse Thrombocytopenia studies →Shandong University is the lead sponsor of 284 studies on the registry; 59 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Dexamethasone 20 mg per day, 4 consecutive days
Drug: Dexamethasone
Dexamethasone 40 mg per day, 4 consecutive days
Drug: Dexamethasone
Dexamethasone was given at a dose of 40 mg,daily for 4 consecutive days
Dexamethasone was given at a dose of 20 mg,daily for 4 consecutive days
Proposed criteria for assessing early response to ITP treatments
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.
Time frame: 3 months
Safety
The type and frequency of therapy associated adverse events
Time frame: 1 years
This study is completed, as verified in May 2014. You cannot join it, but the record below documents what was studied.
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Shandong University