IGIV Study for Chronic ITP Patients Ages 3-70
| Status: | Completed |
|---|---|
| Conditions: | Hematology |
| Therapuetic Areas: | Hematology |
| Healthy: | No |
| Age Range: | 3 - 70 |
| Updated: | 4/21/2016 |
| Start Date: | February 2008 |
| End Date: | March 2012 |
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
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.
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.
Inclusion Criteria:
- Eligible subjects must be 3 to 70 years of age
- Must have a diagnosis of chronic ITP
- Must have a a platelet count ≤ 20 x 10(9)/L
We found this trial at
32
sites
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Connecticut Children's Medical Center Connecticut Children’s Medical Center is a nationally recognized, 187-bed not-for-profit children’s...
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Children's Hospital of Orange County For more than 45 years, CHOC Children’s has been steadfastly...
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Cleveland Clinic Florida Cleveland Clinic Florida, located in Weston, West Palm Beach, Palm Beach Gardens...
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Cook Children's Medical Center Cook Children's Health Care System is a not-for-profit, nationally recognized pediatric...
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Phoenix Children's Hospital Phoenix Children's Hospital has provided hope, healing, and the best healthcare for...
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Georgetown University Georgetown University is one of the world's leading academic and research institutions, offering...
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