NCT02642380

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

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

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Shandong University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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 description

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.

Conditions

• Immune Thrombocytopenia

Interventions

Type	Name	Description
DRUG	Dexamethasone (4 cycles)	dexamethasone 40mg daily for 4 consecutive days every 14 days for 4 courses
DRUG	Dexamethasone (1 cycle)	dexamethasone 40mg daily for 4 consecutive days

Timeline

• Start date: 2015-11-01
• Primary completion: 2018-11-01
• Completion: 2018-11-01
• First posted: 2015-12-30
• Last updated: 2016-04-20

Locations

1 site across 1 country: China