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)

NCT07059000 Phase 3 RECRUITING

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

Details

Lead sponsor	Kedrion S.p.A.
Phase	Phase 3
Status	RECRUITING
Enrolment	40
Start date	2025-08-13
Completion	2026-08

Conditions

• Chronic Primary Immune Thrombocytopenia (ITP)

Interventions

• Kedrion IVIG 10%

Primary outcomes

• Rate of subjects with response (R) — Treatment to day 14
  Assess the responder rate by measuring the platelet count increase according to the Response (R) definition and the absence of bleeding during the evaluation period

Countries

United States, Czechia, Germany, Italy, Romania, Serbia, Spain, Turkey (Türkiye)