Clinical Trial: Different Cycles of High-dose Dexamethasone for Initial Management of Primary Immune Thrombocytopenia (ITP)

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

Official Title: Different Cycles of High-dose Dexamethasone for Initial Management of Primary Immune Thrombocytopenia (ITP): a Prospective, Randomized Controlled Trial

Brief Summary: The project was organized by Qilu Hospital of Shandong University in China. In order to report the efficacy and safety of different cycles of high-dose dexamethasone for the treatment of adults with newly-diagnosed primary immune thrombocytopenia (ITP).

Detailed Summary:

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.


Sponsor: Shandong University

Current Primary Outcome: sustained response to treatment [ Time Frame: 6 months after treatment started ]

percentage of patients maintaining PLT count over 30*10^9 without bleeding


Original Primary Outcome: Same as current

Current Secondary Outcome: 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.



Original Secondary Outcome: Same as current

Information By: Shandong University

Dates:
Date Received: December 24, 2015
Date Started: November 2015
Date Completion: November 2018
Last Updated: April 18, 2016
Last Verified: December 2015