NCT02834468

DEX Combined With RTX, CSA and IVIG in the Management of Newly Diagnosed ITP Patients

A Multicenter Randomized Study of Dexamethasone Combined With Rituximab, Cyclosporin and Intravenous Immunoglobulin in the Management of Newly Diagnosed ITP Patients

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Shandong University · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

The project was undertaken by Qilu Hospital, Shandong University in China. In order to report the efficacy and safety of dexamethasone combined with rituximab, cyclosporin and intravenous immunoglobulin in the management of newly diagnosed ITP patients.

Detailed description

The investigators are undertaking a multicenter trial of 100 primary ITP adult patients from 5 medical centers in China. All participants receive dexamethasone (given orally at a dose of 40 mg per day for 4 days), rituximab (given intravenously at a dose of 500mg once), cyclosporin (given orally at a dose of 2.5-3 mg/kg per day for 28 days) and intravenous immunoglobulin (given intravenously at a dose of 5g per month for 6 months) for the treatment of adults newly diagnosed ITP patients.

Conditions

• Immune Thrombocytopenia

Interventions

Type	Name	Description
DRUG	DEX Combined With RTX, CSA and IVIG	The investigators are undertaking a multicenter trial of 100 primary ITP adult patients from 5 medical centers in China. All participants receive dexamethasone (given orally at a dose of 40 mg per day for 4 days), rituximab (given intravenously at a dose of 500mg once), cyclosporin (given orally at a dose of 2.5-3 mg/kg per day for 28 days) and intravenous immunoglobulin (given intravenously at a dose of 5g per month for 6 months) for the treatment of adults newly diagnosed ITP patients.

Timeline

• Start date: 2016-06-01
• Primary completion: 2018-07-01
• Completion: 2018-12-01
• First posted: 2016-07-15
• Last updated: 2016-07-15

Locations

1 site across 1 country: China