Clinical Trial: Efficacy and Safety Study of a 10% Triple Virally Reduced Intravenous Immune Globulin Solution in Adult Subjects With Chronic Idiopathic Thrombocytopenic Purpura
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Prospective Open-Label Study of the Efficacy and Safety of Immune Globulin Intravenous (Human), 10% TVR Solution in Adult Subjects With Chronic Idiopathic Thrombocytopenic Purpur
Brief 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.
Detailed Summary:
Sponsor: Baxalta US Inc.
Current Primary Outcome: Subjects Who Qualify As Treatment Responders [ Time Frame: Baseline thru Day 15 post treatment ]
Original Primary Outcome:
Current Secondary Outcome:
- Time to achieve a platelet count > 50 x 109/L
- duration of Duration of platelet response
- Maximum Platelet Count
- Safety In Terms Of Adverse Experiences
Original Secondary Outcome:
Information By: Baxalta US Inc.
Dates:
Date Received: September 8, 2005
Date Started: January 2003
Date Completion:
Last Updated: June 26, 2015
Last Verified: October 2006