Clinical Trial: An Investigation of Dexamethasone With Different Doses in the Management of Immune Thrombocytopenia (ITP)

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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)

Brief Summary: 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).

Detailed Summary:

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).


Sponsor: Shandong University

Current Primary Outcome: Proposed criteria for assessing early response to ITP treatments [ Time Frame: 3 months ]

  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.


Original Primary Outcome: Same as current

Current Secondary Outcome: Safety [ Time Frame: 1 years ]

The type and frequency of therapy associated adverse events


Original Secondary Outcome: Same as current

Information By: Shandong University

Dates:
Date Received: May 29, 2014
Date Started: May 2014
Date Completion:
Last Updated: April 18, 2016
Last Verified: May 2014