Kronik İmmün Trombositopeni (ITP) Tanısı Konmuş Erişkin Hastalarda KEdrion İntravenöz İnsan Normal İmmünoglobulin (IVIg) %10'un Etkinliğini ve Güvenliğini Deüğerlendirmek Amacıyla Yapılan Faz3, Açık Etiketli, Tek Kollu, Prospektif, Çok Merkezli Bir Çalışma

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Tarkun P. (Yürütücü)

• Proje Türü: Desteklenmiş Diğer Projeler
• Proje Grubu: Tıp Sağlık
• Projenin Yürütüldüğü Birim: Tıp Fakültesi
• Başlangıç Tarihi: Haziran 2026
• Bitiş Tarihi: Haziran 2029

Özet

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 withChronic 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 withChronic 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 withChronic Immune Thrombocytopenia (ITP)

Each subject will participate in the study for approximately 37 days from signing an Informed Consent Form (ICF) to the End of Study (EOS) Visit (Day 30). This includes a screening period, a Baseline Visit, a treatment course, and subsequent visits for safety and efficacy assessment until the EOS Visit.Each subject will participate in the study for approximately 37 days from signing an Informed Consent Form (ICF) to the End of Study (EOS) Visit (Day 30). This includes a screening period, a Baseline Visit, a treatment course, and subsequent visits for safety and efficacy assessment until the EOS Visit.