NCT00511147

IGIV Study for Chronic ITP Patients Ages 3-70

A Multi-center, Prospective, Open-label, Clinical Trial to Assess the Safety and the Efficacy of a New Intravenous Immune Globulin (IGIV3I Grifols 10%) in Patients With Idiopathic (Immune) Thrombocytopenic Purpura

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Grifols Biologicals, LLC · Industry
• Sex: All
• Age: 3 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Idiopathic (immune) thrombocytopenic purpura (ITP) is an autoimmune disorder characterized by platelet destruction and thrombocytopenia (peripheral blood platelet count \< 150 x 10\^9/L). IVIG therapy is useful in patients in whom the platelet count has to be raised either due to bleeding signs, or where bleeding is predicted (e.g., surgery or parturition). The primary goal of treatment is to maintain the platelet count at a hemostatic level. This study will test the safety and efficacy of IGIV3I Grifols 10% in the treatment of patients with chronic ITP.

Conditions

• Idiopathic Thrombocytopenic Purpura

Interventions

Type	Name	Description
BIOLOGICAL	IGIV3I Grifols 10%	IGIV3I Grifols 10% 1 g/kg/day given on two consecutive days, Day 1 and Day 2, for a total dose of 2 g/kg over two days.

Timeline

• Start date: 2008-05-01
• Primary completion: 2014-04-01
• Completion: 2014-04-01
• First posted: 2007-08-03
• Last updated: 2017-06-12
• Results posted: 2017-05-05

Locations

45 sites across 4 countries: United States, Canada, India, Puerto Rico

Regulatory

• FDA-regulated drug study