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NCT07059000PHASE3Recruiting

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

Kedrion S.p.A.

Start Date

8/13/2025

Completion Date

1/1/2027

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 Criteria

Age Range: 18 years to 70 years

Inclusion Criteria: 1. Male or female, 18-70 years of age. 2. Patient has signed the ICF. 3. Diagnosis of chronic (\> 12 months duration) ITP as defined by the International Working Group. 4. 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. 5. A pre-infusion platelet count of \< 30 × 10\^9/L at the Baseline Visit. 6. Patient is willing to comply with all requirements of the protocol. 7. 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. 8. Authorization to access personal health information. Exclusion Criteria: 1. Patients incapable of giving informed consent. 2. 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). 3. Patients with Evans Syndrome. 4. Patients known to be infected with hepatitis B virus, hepatitis C virus, or HIV. 5. History of thrombotic events including deep vein thrombosis, cerebrovascular accident, pulmonary embolism, transient ischemic attacks, or myocardial infarction. 6. Patient with a history of hypersensitivity to IVIg, other injectable forms of IVIg, or to any of the excipients. 7. Patient unresponsive previously to IVIg or anti-D Ig treatment. 8. Patient with known Immunoglobulin A (IgA) deficiency and antibodies against IgA. 9. Splenectomy within 4 weeks of the Baseline Visit or planned splenectomy throughout the study period. 10. Participants with known inherited thrombocytopenia. e.g., MYH-9 disorders. 11. Participants with myelodysplastic syndrome (MDS). 12. 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: 1. patients on a stable dose of TPO-RA within 4 weeks of the Baseline Visit 2. patients on a stable dose of Mycophenolate Mofetil within 3 months of the Baseline Visit 3. patients on stable dose of Danazol within 3 months of the Baseline Visit 4. 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 5. 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. 13. Received any blood, blood product, or blood derivative within 1 month of the Baseline Visit. 14. Received rituximab within 6 months of the Baseline Visit. 15. Had a platelet transfusion or receipt of blood products containing platelets within 7 days of Visit 1 (Day 1). 16. Received recombinant activated factor VII within 7 days of the Baseline Visit. 17. Had therapy with live attenuated virus vaccines within 3 months of the Baseline Visit. 18. Use of loop diuretics within 1 week of the Baseline Visit. 19. Patients at high risk of thrombotic events. 20. 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. 21. Congestive heart failure as per New York Heart Association III/IV, cardiomyopathy, cardiac arrhythmia associated with thromboembolic events (e.g., atrial fibrillation), unstable or advanced ischemic heart disease, hyperviscosity. 22. Patients with significant protein losing enteropathy, nephrotic syndrome, or lymphangiectasia. 23. Patients with hyperproteinemia, increased serum viscosity, and/or hyponatremia. 24. Severe liver or kidney disease (normal reference ranges of laboratory doing the analysis): 1. alanine aminotransferase (ALT) or aspartate amino transferase (AST) 2.5x \> upper limit of normal (ULN) 2. creatinine \> 120 μmol/L 3. blood urea nitrogen (BUN) \> 2.5x ULN 25. Signs of severe anemia: Hemoglobin of less than 7 g/dL, hemodynamically unstable due to active bleeding, and/or when evidence of end-organ ischemia secondary to severe anemia is present. 26. Body mass index \> 40 kg/m2 or an IVIg dose that puts the patient at risk of fluid overload. 27. History of a malignant disease within 3 years of the Baseline Visit other than properly treated carcinoma in situ of the cervix or basal cell or squamous cell carcinoma of the skin. 28. Patient has participated in an interventional, investigational clinical study within 30 days of the Baseline Visit or within 5 half-lives of the investigational medicinal product (IMP) under investigation. 29. Any condition that the Investigator believes is likely to interfere with evaluation of the IMP or with satisfactory conduct of the trial.

Interventions

BIOLOGICAL

Kedrion IVIG 10%

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Conditions

Chronic Primary Immune Thrombocytopenia (ITP)

Locations

University of Southern California

Los Angeles, California 90033

United States

NY Cancer and Blood Specialists

Shirley, New York 11967

United States

East Carolina University

Greenville, North Carolina 27834

United States

Vseobecna Fakultni Nemocnice v Praze

Prague, Prague 128 08

Czechia

Fakultni Nemocnice Brno

Brno, South Moravian 625 00

Czechia

Onkologisches Zentrum Donauwörth Neudegger - Onkomedeor Onkologische Zentren

Donauwörth, Bavaria 86609

Germany

Universitätsklinikum Frankfurt

Frankfurt am Main, Hesse 60590

Germany

Azienda Ospedaliero - Universitaria Careggi

Florence, Florence 50134

Italy

Azienda Ospedaliero-Universitaria Maggiore della Carità di Novara

Novara, Novara 28100

Italy

Azienda Sanitaria Universitaria Giuliano Isontina

Trieste, Trieste 34148

Italy

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

Torino, Turin 10126

Italy

AULSS 8 Berica - Ospedale San Bortolo Di Vicenza

Vicenza, Vicenza 36100

Italy

Coltea - Spital Clinic

Bucharest, Bucharest 030 171

Romania

Institutul Oncologic Prof. Dr. Ion Chiricuta

Cluj-Napoca, Cluj 400015

Romania

Spitalul Filantropia - Craiova

Craiova, Dolj 200143

Romania

Univerzitetski Klinicki Centar Srbije

Belgrade, 11000

Serbia

Klinicko-Bolnicki Centar Zemun

Belgrade, 11080

Serbia

Complejo Asistencial Universitario de Burgos - Hospital Universitario de Burgos

Burgos, Burgos 09006

Spain

Instituto De Investigacion Biomedica De A Coruna - Virologia Clinica

A Coruña, La Coruña 15006

Spain

Complejo Hospitalario Ruber Juan Bravo

Madrid, Madrid 28006

Spain

Hospital General Universitario Gregorio Marañón

Madrid, Madrid 28007

Spain

Ankara Üniversitesi Tip Fakültesi - Cebeci Arastirma ve Uygulama Hastanesi

Ankara, Ankara 06100

Turkey (Türkiye)

Kocaeli Üniversitesi Arastirma ve Uygulama Hastanesi

Ankara, Ankara 06680

Turkey (Türkiye)

Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi

Yenimahalle, Ankara 06200

Turkey (Türkiye)

Trakya Üniversitesi Saglik Arastirma ve Uygulama Merkezi

Edirne, Edirne 22130

Turkey (Türkiye)

Ege Universitesi Tip Fakultesi

Izmir, İzmir 35040

Turkey (Türkiye)

VM Medical Park Mersin Hastanesi

Mersin, Mersin 33200

Turkey (Türkiye)

Sakarya Universitesi Egitim ve Arastirma Hastanesi

Adapazarı, Sakarya 54100

Turkey (Türkiye)