NCT00699140

Clinical Trial in Patients Diagnosed With Immune Thrombocytopenic Purpura

Clinical Trial to Evaluate the Efficacy and the Safety of IGIV3I Grifols 10% (Human Intravenous Immunoglobulin) in Patients Diagnosed With Immune Thrombocytopenic Purpura

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Instituto Grifols, S.A. · Industry
• Sex: All
• Age: 18 Years – 82 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether IGIV3I Grifols 10% is effective in the treatment of immune thrombocytopenic purpura.

Detailed description

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.

Conditions

• Immune (Idiopathic) Thrombocytopenic Purpura

Interventions

Type	Name	Description
BIOLOGICAL	IGIV3I Grifols	Immune Globulin Intravenous (Human)

Timeline

• Start date: 2008-02-01
• Primary completion: 2013-12-01
• Completion: 2013-12-01
• First posted: 2008-06-17
• Last updated: 2016-02-08
• Results posted: 2016-02-08

Locations

7 sites across 3 countries: Russia, Spain, United Kingdom