NCT00162006

Efficacy and Safety Study of a 10% Triple Virally Reduced Intravenous Immune Globulin Solution in Adult Subjects With Chronic Idiopathic Thrombocytopenic Purpura

Prospective Open-Label Study of the Efficacy and Safety of Immune Globulin Intravenous (Human), 10% TVR Solution in Adult Subjects With Chronic Idiopathic Thrombocytopenic Purpura

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Baxalta now part of Shire · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate whether Immune Globulin Intravenous (Human), 10% TVR (Triple Virally Reduced) Solution is an effective and safe treatment in patients with chronic idiopathic thrombocytopenic purpura.

Conditions

• Immune Thrombocytopenic Purpura (ITP)

Interventions

Type	Name	Description
DRUG	Immune Globulin Intravenous (Human), 10% Triple Virally Reduced Solution

Timeline

• Start date: 2003-01-13
• Primary completion: 2003-12-03
• Completion: 2003-12-03
• First posted: 2005-09-13
• Last updated: 2021-05-03

Locations

11 sites across 4 countries: Czechia, Germany, Hungary, Poland