Thrombocytopenia
A Multi-Center, Prospective, Open-Label, Clinical Trial to Assess the Safety and the Efficacy of a New Intravenous Immune Globulin (IGIV31 Grifols 10%) in Patients with Idiopathic (Immune) Thrombocytopenic Purpura
Eligibility Criteria (per Protocol dated 05/24/07):
- Subject must be clinically diagnosed with ITP.
- When administered corticosteroids at any time within 3 weeks before the screening visit, the subject must have completed at least 3 weeks (21 days) of therapy at a stable and constant dose and schedule prior to the screening visit.
- When administered azathioprine (an immunosuppressant) at any time within 3 months before the screening visit, the subject must have received a stable dose and schedule for at least 3 months prior to the screening visit.
- When administeredvinca alkaloids, (e.g., vincristine) at any time within 2 weeks before the screening visit, the subject must have received a stable dose and schedule for at least 2 weeks prior to the screening visit.
- When administered atenuated androgens, (e.g., danzol) at any time within 8 weeks before the screening visit, the subject must have received a stable dose and schedule for at least 8 weeks prior to the screening visit.
- Subject not eligible if there is a history or clinical evidence of medical conditions (other than ITP) felt to be the underlying cause of thrombocytopenia.
- Subject not eligible if there is a history of severe (anaphylactic) reactions to blood or any blood-derived product.
- Subject not eligible if there is a history of intolerance to any component of the IP, such as sorbitol.
- Subject not eligible if there is known immunoglobulin A (IgA) deficiency.
- Other criteria, as determined by the protocol.
For information about this study, please contact Robin Stewart, RN, PhD, CCRC at (863) 904-1877.