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 ]

Subjects who i) had at least one platelet count of ≥50 x 109/L prior to Day 15 and ii) did not require a booster dose prior to Day 15, where Day 15 refers to the fifteenth day after initiation of treatment (Day 1). Otherwise, the subject is a non-responder.


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