RecruitingPhase 3NCT07059000

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)

Sponsor

Kedrion S.p.A.

Enrollment

40 participants

Start Date

Aug 13, 2025

Study Type

INTERVENTIONAL

Conditions

Chronic Primary Immune Thrombocytopenia (ITP)

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

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a biological treatment called Kedrion IVIG 10% for people with chronic primary immune thrombocytopenia (itp). The study is currently recruiting participants at 27 locations. People eligible for this study include aged 18 Years to 70 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALKedrion IVIG 10%

(Intravenous) Human Normal Immunoglobulin (IVIg) 10%

Locations(27)

University of Southern California

Los Angeles, California, United States

East Carolina University

Greenville, North Carolina, United States

Vseobecna Fakultni Nemocnice v Praze

Prague, Prague, Czechia

Fakultni Nemocnice Brno

Brno, South Moravian, Czechia

Onkologisches Zentrum Donauwörth Neudegger - Onkomedeor Onkologische Zentren

Donauwörth, Bavaria, Germany

Universitätsklinikum Frankfurt

Frankfurt am Main, Hesse, Germany

Azienda Ospedaliero - Universitaria Careggi

Florence, Florence, Italy

Azienda Ospedaliero-Universitaria Maggiore della Carità di Novara

Novara, Novara, Italy

Azienda Sanitaria Universitaria Giuliano Isontina

Trieste, Trieste, Italy

Azienda Ospedaliero-Universitaria Citta della Salute e della Scienza di Torino

Torino, Turin, Italy

AULSS 8 Berica - Ospedale San Bortolo Di Vicenza

Vicenza, Vicenza, Italy

Coltea - Spital Clinic

Bucharest, Bucharest, Romania

Institutul Oncologic Prof. Dr. Ion Chiricuta

Cluj-Napoca, Cluj, Romania

Spitalul Filantropia - Craiova

Craiova, Dolj, Romania

Univerzitetski Klinicki Centar Srbije

Belgrade, Serbia

Klinicko-Bolnicki Centar Zemun

Belgrade, Serbia

Complejo Asistencial Universitario de Burgos - Hospital Universitario de Burgos

Burgos, Burgos, Spain

Instituto De Investigacion Biomedica De A Coruna - Virologia Clinica

A Coruña, La Coruña, Spain

Complejo Hospitalario Ruber Juan Bravo

Madrid, Madrid, Spain

Hospital General Universitario Gregorio Marañón

Madrid, Madrid, Spain

Ankara Üniversitesi Tip Fakültesi - Cebeci Arastirma ve Uygulama Hastanesi

Ankara, Ankara, Turkey (Türkiye)

Kocaeli Üniversitesi Arastirma ve Uygulama Hastanesi

Ankara, Ankara, Turkey (Türkiye)

Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi

Yenimahalle, Ankara, Turkey (Türkiye)

Trakya Üniversitesi Saglik Arastirma ve Uygulama Merkezi

Edirne, Edirne, Turkey (Türkiye)

Ege Universitesi Tip Fakultesi

Izmir, İzmir, Turkey (Türkiye)

VM Medical Park Mersin Hastanesi

Mersin, Mersin, Turkey (Türkiye)

Sakarya Universitesi Egitim ve Arastirma Hastanesi

Adapazarı, Sakarya, Turkey (Türkiye)

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NCT07059000

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