High-dose Dexamethasone Versus Conventional Dose Prednisone for Initial Treatment of Primary Immune Thrombocytopenia (ITP)
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|ClinicalTrials.gov Identifier: NCT01356511|
Recruitment Status : Completed
First Posted : May 19, 2011
Last Update Posted : April 20, 2016
|Condition or disease||Intervention/treatment||Phase|
|Purpura, Thrombocytopenic, Idiopathic||Drug: Prednisone Drug: Dexamethasone||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||261 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||High-dose Dexamethasone and Conventional Dose Prednisone, for the First-line Treatment of Adults With ITP: a Multicenter, Randomized Controlled, Clinical Trial|
|Study Start Date :||September 2010|
|Actual Primary Completion Date :||May 2014|
|Actual Study Completion Date :||March 2015|
Experimental: Prednisone group
Patients in the PDN arm received PDNorally at 1.0mg/kg body weight daily for 4 consecutive weeks.
Prednisone, po, 1 mg/kg/d, for 4 weeks.
Other Name: CD-PRE
Experimental: Dexamethasone group
DXM was administered orally at 40 mg daily for 4 consecutive days and then stopped
Dexamethasone, po, 40 mg/d, for 4 days.
Other Name: HD-DXM
- Proposed criteria for assessing response to ITP treatments [ Time Frame: The time frame is up to 28 days per subject ]
- 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): NCT01356511
|Qilu Hospital, Shandong University|
|Jinan, Shandong, China|
|Principal Investigator:||Ming Hou, DR.||Shandong University|