A Phase III, Open-label, Single Arm, Prospective, Multicenter Study to Assess Efficacy and Safety of Kedrion Intravenous Human Normal Immunoglobulin (IVIg) 10% in Adult Patients With Chronic Immune Thrombocytopenia (ITP)
Kedrion S.p.A.
Summary
The purpose of this study is to evaluate the efficacy and safety of KIg 10 (Intravenous Immunoglobulin 10%) in adult patients with chronic primary ITP
Eligibility
- Age range
- 18–70 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Male or female, 18-70 years of age. 2. Patient and/or legal authorized representative has signed the ICF. 3. Diagnosis of chronic (\> 12 months duration) ITP as defined by the International Working Group. 4. Mean screening platelet count of \< 30 × 10\^9/L from two qualifying counts measured at least one calendar day apart. The first qualifying count can be from historical data if measured within 14 days prior to the first KIg10 infusion. The second qualifying count will be measured within 7 days before the first KIg10 infusion. 5. Platelet count of \< 30 × 10\^9/L at t…
Interventions
- BiologicalKedrion IVIG 10%
(Intravenous) Human Normal Immunoglobulin (IVIg) 10%
Locations (27)
- University of Southern CaliforniaLos Angeles, California
- East Carolina UniversityGreenville, North Carolina
- Vseobecna Fakultni Nemocnice v PrazePrague, Prague
- Fakultni Nemocnice BrnoBrno, South Moravian
- Onkologisches Zentrum Donauwörth Neudegger - Onkomedeor Onkologische ZentrenDonauwörth, Bavaria
- Universitätsklinikum FrankfurtFrankfurt am Main, Hesse