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

Recruiting now · Phase 3

Conditions studied: Chronic Primary Immune Thrombocytopenia (ITP)

In brief

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

Key facts

Study ID: NCT07059000
Run by: Kedrion S.p.A.
People needed: 40
Starts: 2025-08-13
Expected to finish: 2027-01-01
Last updated by the study team: 2026-08-06

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Male or female, 18-70 years of age.
Patient has signed the ICF.
Diagnosis of chronic (> 12 months duration) ITP as defined by the International Working Group.
Mean screening platelet count of < 30 × 10\^9/L from two qualifying counts measured at least one calendar day apart. The first qualifying count can be from historical data if measured within 7 days prior to screening. The second qualifying count will be measured within 7 days before the first KIg10 infusion.
A pre-infusion platelet count of < 30 × 10\^9/L at the Baseline Visit.
Patient is willing to comply with all requirements of the protocol.
Women of childbearing potential (WOCBP) must have a negative urine pregnancy test at screening and agree to employ adequate birth control measures during the study.
Authorization to access personal health information.

You may not qualify if…

Patients incapable of giving informed consent.
Patients with secondary ITP (all forms of immune-mediated thrombocytopenia except primary ITP). e.g., lupus erythematosus, rheumatoid arthritis, drug-related ITP, and Human Immunodeficiency Virus (HIV).
Patients with Evans Syndrome.
Patients known to be infected with hepatitis B virus, hepatitis C virus, or HIV.
History of thrombotic events including deep vein thrombosis, cerebrovascular accident, pulmonary embolism, transient ischemic attacks, or myocardial infarction.
Patient with a history of hypersensitivity to IVIg, other injectable forms of IVIg, or to any of the excipients.
Patient unresponsive previously to IVIg or anti-D Ig treatment.
Patient with known Immunoglobulin A (IgA) deficiency and antibodies against IgA.
Splenectomy within 4 weeks of the Baseline Visit or planned splenectomy throughout the study period.
Participants with known inherited thrombocytopenia. e.g., MYH-9 disorders.
Participants with myelodysplastic syndrome (MDS).
Administration of IVIg, anti-D immunoglobulin, Mercaptopurine, Vinca alkaloid, or platelet enhancing drugs (including thrombopoietin receptor agonists [TPO-RA], immunosuppressive, or other immunomodulatory drugs) within 3 weeks of the Baseline Visit, except for:
patients on a stable dose of TPO-RA within 4 weeks of the Baseline Visit
patients on a stable dose of Mycophenolate Mofetil within 3 months of the Baseline Visit
patients on stable dose of Danazol within 3 months of the Baseline Visit
long-term corticosteroid therapy for ITP, when the dose had been stable within 3 weeks of the Baseline Visit and no dosage change was planned until the EOS Visit
long-term azathioprine, cyclophosphamide, or attenuated androgen therapy when the dose had been stable within 3 months of the Baseline Visit, and no dosage change was planned until after study completion. Treatment with any other products licensed for primary chronic ITP is also exclusive. An appropriate wash-out period must be determined in case of patients who might be eligible for treatment with IVIg.
Received any blood, blood product, or blood derivative within 1 month of the Baseline Visit.
Received rituximab within 6 months of the Baseline Visit.
Had a platelet transfusion or receipt of blood products containing platelets within 7 days of Visit 1 (Day 1).
Received recombinant activated factor VII within 7 days of the Baseline Visit.
Had therapy with live attenuated virus vaccines within 3 months of the Baseline Visit.
Use of loop diuretics within 1 week of the Baseline Visit.
Patients at high risk of thrombotic events.
Uncontrolled hypertension [i.e., diastolic blood pressure >100 mmHg and/or systolic blood pressure >160 mmHg]. If a single measure exceeds this limit, a triple repeat measurement may be performed and the average of the three measurements used.

Where it is running

Sakarya Universitesi Egitim ve Arastirma Hastanesi — Adapazarı, Sakarya, Turkey (Türkiye) (enrolling)
NY Cancer and Blood Specialists — Shirley, New York, United States (enrolling)
East Carolina University — Greenville, North Carolina, United States (enrolling)
Vseobecna Fakultni Nemocnice v Praze — Prague, Prague, Czechia (enrolling)
Fakultni Nemocnice Brno — Brno, South Moravian, Czechia (enrolling)
Ankara Üniversitesi Tip Fakültesi - Cebeci Arastirma ve Uygulama Hastanesi — Ankara, Ankara, Turkey (Türkiye) (enrolling)
Kocaeli Üniversitesi Arastirma ve Uygulama Hastanesi — Ankara, Ankara, Turkey (Türkiye) (enrolling)
Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi — Yenimahalle, Ankara, Turkey (Türkiye) (enrolling)
VM Medical Park Mersin Hastanesi — Mersin, Mersin, Turkey (Türkiye) (enrolling)
University of Southern California — Los Angeles, California, United States (enrolling)
Universitätsklinikum Frankfurt — Frankfurt am Main, Hesse, Germany (enrolling)
Azienda Ospedaliero - Universitaria Careggi — Florence, Florence, Italy (enrolling)
Azienda Ospedaliero-Universitaria Maggiore della Carità di Novara — Novara, Novara, Italy (enrolling)
Azienda Sanitaria Universitaria Giuliano Isontina — Trieste, Trieste, Italy (enrolling)
Azienda Ospedaliero-Universitaria Citta della Salute e della Scienza di Torino — Torino, Turin, Italy (enrolling)
AULSS 8 Berica - Ospedale San Bortolo Di Vicenza — Vicenza, Vicenza, Italy (enrolling)
Coltea - Spital Clinic — Bucharest, Bucharest, Romania (enrolling)
Institutul Oncologic Prof. Dr. Ion Chiricuta — Cluj-Napoca, Cluj, Romania (enrolling)
Spitalul Filantropia - Craiova — Craiova, Dolj, Romania (enrolling)
Univerzitetski Klinicki Centar Srbije — Belgrade, Serbia (enrolling)
Instituto De Investigacion Biomedica De A Coruna - Virologia Clinica — A Coruña, La Coruña, Spain (enrolling)
Complejo Hospitalario Ruber Juan Bravo — Madrid, Madrid, Spain (enrolling)
Hospital General Universitario Gregorio Marañón — Madrid, Madrid, Spain (enrolling)
Onkologisches Zentrum Donauwörth Neudegger - Onkomedeor Onkologische Zentren — Donauwörth, Bavaria, Germany
Trakya Üniversitesi Saglik Arastirma ve Uygulama Merkezi — Edirne, Edirne, Turkey (Türkiye)

Full record on ClinicalTrials.gov

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