NCT03258866

The Study of Different Dose Rituximab in the Treatment of ITP

The Clinical Randomized Controlled Study of Different Dose Rituximab in the Treatment of Primary Immune Thrombocytopenia

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 62 (actual)
• Sponsor: Shandong University · Academic / Other
• Sex: All
• Age: 10 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The project was undertaking by Qilu Hospital of Shandong University in China. In order to compare the efficacy, safety and response duration of different dose of rituximab in patients primary immune thrombocytopenia(pITP).

Detailed description

62 patients with pITP who had failed to respond to glucocorticosteroids were randomly divided into 2 groups: group A(n = 32) and group B(n = 30). In group A, Rituximab was given with a fixed dose of 100 mg administered as an intravenous infusion weekly (on day 1, 8, 15 and 22). In group B, Rituximab was given with a single dose of 375mg/m2. The clinical effect, onset time, duration of efficacy and adverse reactions were observed to compare the efficacy and safety of two different plans.

Conditions

• Purpura, Thrombocytopenic, Idiopathic
• Immune Thrombocytopenia

Interventions

Type	Name	Description
DRUG	Rituximab	given with a fixed dose of 100 mg administered as an intravenous infusion weekly (on day 1, 8, 15 and 22)
DRUG	Rituximab	given with a single dose of 375mg/m2

Timeline

• Start date: 2010-01-01
• Primary completion: 2015-12-31
• Completion: 2016-12-31
• First posted: 2017-08-23
• Last updated: 2017-08-23

Locations

1 site across 1 country: China