Recruiting PHASE3 INTERVENTIONAL 1-arm NCT07059000

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

Sponsor: ICON plc

Conditions Chronic Primary Immune Thrombocytopenia (ITP)

Interventions Kedrion IVIG 10%

Updated 6 times since 2025 Last updated: Mar 12, 2026 Started: Aug 13, 2025 Primary completion: Aug 31, 2026 Completion: Aug 31, 2026

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE3 trial investigates Chronic Primary Immune Thrombocytopenia (ITP) and is currently actively recruiting participants. ICON plc leads this study, which shows 6 recorded versions since 2025 — indicating limited longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Status Flow

Change History

6 versions recorded

Mar 2026 — Present [monthly]

Recruiting PHASE3
Feb 2026 — Mar 2026 [monthly]

Recruiting PHASE3
Jan 2026 — Feb 2026 [monthly]

Recruiting PHASE3
Dec 2025 — Jan 2026 [monthly]

Recruiting PHASE3
Sep 2025 — Dec 2025 [monthly]

Recruiting PHASE3

Status: Not Yet Recruiting → Recruiting

▶ Show 1 earlier version

Aug 2025 — Sep 2025 [monthly]

Not Yet Recruiting PHASE3

First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

ICON plc
Kedrion S.p.A.

Data source: Kedrion S.p.A.

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

A Coruña, Spain , Adapazarı, Turkey (Türkiye) , Ankara, Turkey (Türkiye) , Belgrade, Serbia , Brno, Czechia , Bucharest, Romania , Burgos, Spain , Cluj-Napoca, Romania , Craiova, Romania , Donauwörth, Germany and 14 more locations