IGIV Study for Chronic ITP Patients Ages 3-70

Completed · Phase 3

Conditions studied: Idiopathic Thrombocytopenic Purpura

In brief

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.

Key facts

Study ID

NCT00511147

Run by

Grifols Biologicals, LLC

People needed

64

Starts

2008-05-01

Expected to finish

2014-04-01

Last updated by the study team

2017-06-12

Who can join

Age: 3 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

Where it is running

• Phoenix Children's Hospital — Phoenix, Arizona, United States
• Scottsdale Medical Specialists — Scottsdale, Arizona, United States
• Arizona Oncology Associates — Tucson, Arizona, United States
• Scripps Cancer Center — La Jolla, California, United States
• Kenmar Research Institute, LLC — Los Angeles, California, United States
• Children's Hospital of Orange County — Orange, California, United States
• Connecticut Children's Medical Center — Hartford, Connecticut, United States
• Cancer Center of Central Connecticut — Southington, Connecticut, United States
• Georgetown University — Washington D.C., District of Columbia, United States
• VA Medical Center — Washington D.C., District of Columbia, United States
• Halifax Health Medical Center — Daytona Beach, Florida, United States
• Hematology Oncology Associates — Lake Worth, Florida, United States
• Lakeland Regional Cancer Center — Tampa, Florida, United States
• St. Joseph's Children's Hospital of Tampa — Tampa, Florida, United States
• Cleveland Clinic Florida — Weston, Florida, United States
• Emory University School of Medicine Winship Cancer Center — Atlanta, Georgia, United States
• Advocate Hope Children's Hospital — Oak Lawn, Illinois, United States
• University of Iowa Children's Hospital — Iowa City, Iowa, United States
• Children's Hospital — New Orleans, Louisiana, United States
• Kalamazoo Hematology & Oncology — Kalamazoo, Michigan, United States
• CTO Breslin Cancer Center/MSU/Great Lakes Cancer Institute — Lansing, Michigan, United States
• University of Mississippi — Jackson, Mississippi, United States
• Capital Comprehensive Cancer Care Clinic — Jefferson City, Missouri, United States
• UMDNJ-RWJ Medical School — New Brunswick, New Jersey, United States
• Mt. Sinai Medical Center — New York, New York, United States

Full record on ClinicalTrials.gov

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