NCT07059000

A Study Investigating Intravenous Human Normal Immunoglobulin 10% in Adults With Chronic Immune Thrombocytopenia (ITP)

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)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Kedrion S.p.A. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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

Conditions

• Chronic Primary Immune Thrombocytopenia (ITP)

Interventions

Type	Name	Description
BIOLOGICAL	Kedrion IVIG 10%	(Intravenous) Human Normal Immunoglobulin (IVIg) 10%

Timeline

• Start date: 2025-08-13
• Primary completion: 2026-08-01
• Completion: 2026-08-01
• First posted: 2025-07-10
• Last updated: 2026-03-13

Locations

27 sites across 8 countries: United States, Czechia, Germany, Italy, Romania, Serbia, Spain, Turkey (Türkiye)

Regulatory

• FDA-regulated drug study