Immune (Idiopathic) Thrombocytopenic Purpura Clinical Trial
Official title:
Clinical Trial to Evaluate the Efficacy and the Safety of IGIV3I Grifols 10% (Human Intravenous Immunoglobulin) in Patients Diagnosed With Immune Thrombocytopenic Purpura
The purpose of this study is to determine whether IGIV3I Grifols 10% is effective in the treatment of immune thrombocytopenic purpura.
To determine if IGIV3I Grifols 10% is a consistently effective treatment in patients
diagnosed with immune thrombocytopenic purpura with respect to:
1. Increase of platelet count ≥ 50x10^9/L (primary objective).
2. Time taken for the platelet count to reach ≥ 50x10^9/L.
3. The length of time the platelet count remains ≥ 50x10^9/L.
4. The maximum platelet level.
5. Regression of bleeding episodes during the first 10 or 14 days.
To determine if IGIV3I Grifols 10% is safe with respect to:
Nature, severity and frequency of adverse reactions during and after infusions by percentage
of subjects and percentage of infusions.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment