Clinical Trial: Treatment of Idiopathic Thrombocytopenic Purpura (ITP) With Subcutaneously Administered Anti-D
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Treatment of Idiopathic Thrombocytopenic Purpura in Children With Subcutaneously Administered Anti-D
Brief Summary: The purpose of this study is to describe the effect of anti-D on symptoms and platelet count in children suffering from unexplainable low platelet counts, when anti-D is administered as an injection under the skin. The hypothesis is that the injection with anti-D under the skin is as effective as anti-D given in a vein.
Detailed Summary:
Background:
Idiopathic thrombocytopenic purpura (ITP) in children is considered a benign hematological disease. The incidence is approximately 50 cases a year in Denmark. Approximately 25 % will experience chronic disease. Follow up and treatment of these patients is not centralized.
The drug of choice is intravenous IgG (IVIG) for treatment of ITP. The side effects are flu-like symptoms, and in rare cases aseptic meningitis. Another option is intravenous anti-D, if the child is rhesus positive. Anti-D is primarily used in North America. The effect of Anti-D is comparable with IVIG when considering the time it takes to bring the platelet count above 50,000/μL. Anti-D also causes flu-like symptoms. Establishing an i.v. access is a disadvantage to both IVIG and anti-D. For both treatments mechanism of action is not finally described.
Subcutaneous IgG substitution therapy is used for patients suffering from agammaglobulinaemia. It is therefore known, that immunoglobulin uptake is possible after subcutaneous administration. Subcutaneous anti-D has been tried in few patients suffering from chronic thrombocytopenia with positive results.
IVIG treatment is expensive compared to anti-D. Treatment of a 20 kg child costs approximately 17,000 Dkr for IVIG and 2,500 Dkr. for anti-D.
Hypothesis:
- Subcutaneous administered anti-D is as effective as IVIG/i.v. anti-D;
- Subcutaneous administered anti-D has fewer less severe side effects than IVIG/i.v. anti-D.
Purpose:
- Clinical effect evaluated on clinical score scale before and after treatment at specified intervals
- Side effects (safety)
Sponsor: University of Aarhus
Current Primary Outcome: Clinical effect evaluated on clinical score scale before and after treatment at specified intervals [ Time Frame: day 0,1,3,6,14,30, 180,360 ]
Original Primary Outcome:
Current Secondary Outcome: Platelet count [ Time Frame: day 0, 1, 3, 6, 14, 30, 180, 360 ]
Original Secondary Outcome: Platelet count
Information By: University of Aarhus
Dates:
Date Received: August 8, 2005
Date Started: November 2004
Date Completion:
Last Updated: February 2, 2009
Last Verified: February 2009
