High-dose Dexamethasone Versus Conventional Dose Prednisone for Initial Treatment of Primary Immune Thrombocytopenia (ITP)
|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.
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|