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)
ESTADO CLÍNICO
Reclutando
FASE/S DEL ENSAYO
Fase III
PATOLOGÍA
Trombopenia inmune primaria, Trombosis y Anticoagulantes, Linfoma
CENTRO INVESTIGADOR
H.G.U. Gregorio Marañón
INVESTIGADOR PRINCIPAL
Cristina Pascual Izquierdo
CENTRO INVESTIGADOR
Hospital Ruber Juan Bravo
INVESTIGADOR PRINCIPAL
Aranzazu Alonso Alonso
FECHA DE APERTURA
Abril, 2025
FECHA DE CIERRE
,
CRITERIOS DE INCLUSIÓN
1. Male or female, 18-70 years of age.
2. Patient and/or legal authorized representative 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 × 109/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 the screening. The second qualifying count will be measured within 7 days before the first KIg10 infusion.
5. Platelet count of < 30 × 109/L at the Baseline Visit.
6. Patient is willing to comply with all requirements of the protocol.
7. Women of childbearing potential 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.
2. Patient and/or legal authorized representative 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 × 109/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 the screening. The second qualifying count will be measured within 7 days before the first KIg10 infusion.
5. Platelet count of < 30 × 109/L at the Baseline Visit.
6. Patient is willing to comply with all requirements of the protocol.
7. Women of childbearing potential 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.
CRITERIOS DE EXCLUSIÓN
1. Patients with secondary ITP
18. Signs of severe anemia
19. BMI > 40 kg/m2 or an IVIg dose that puts the patient at risk of fluid overload
2. Patients with Evans Syndrome, inherited thrombocytopenia, myelodysplastic syndrome
20. History of a malignant disease within 3 years of the Baseline Visit other than treated carcinoma in situ of the cervix or basal cell or squamous cell carcinoma of the skin
21. Patient has participated in an interventional, investigational clinical study within 30 days of the Baseline Visit
3. Patients infected with HBV, HCV or HIV
4. Patients with a history of thrombotic events and/or at high risk of thrombotic events
5. History of hypersensitivity to IVIg or to any of the excipients
6. Patients unresponsive previously to IVIg or anti-D Ig treatment
7. Patients with immunoglobulin A deficiency and Ab against IgA
10. Received platelets within 7days of Visit 1 and any other blood/plasma product within 1 month of the Baseline Visit (BV)
8. Splenectomy within 4 weeks of the Baseline Visit or planned throughout the study
9. Administration of IVIg, anti-D Ig, Mercaptopurine, Vinca alkaloid, or platelet enhancing drugs within 3 weeks of the Baseline Visit unless patients are on stable treatment as defined. Treatment with any other products licensed for primary chronic ITP is also exclusive.
11. Received recombinant activated factor VII within 7 days rituximab within 6 months of the BV
12 Received live attenuated virus vaccines within 3 months of the BV
13. Use of loop diuretics w/i 1 week of the BV
14. Uncontrolled hypertension
15. Congestive heart failure as per New York Heart Association III/IV, cardiomyopathy, cardiac arrhythmia associated with thromboembolic events , unstable or advanced ischemic heart disease, hyperviscosity
16. Patients with significant protein losing enteropathy, nephrotic syndrome, lymphangiectasia, hyperproteinemia, increased serum viscosity and/or hyponatremia
17. Severe liver or kidney disease
18. Signs of severe anemia
19. BMI > 40 kg/m2 or an IVIg dose that puts the patient at risk of fluid overload
2. Patients with Evans Syndrome, inherited thrombocytopenia, myelodysplastic syndrome
20. History of a malignant disease within 3 years of the Baseline Visit other than treated carcinoma in situ of the cervix or basal cell or squamous cell carcinoma of the skin
21. Patient has participated in an interventional, investigational clinical study within 30 days of the Baseline Visit
3. Patients infected with HBV, HCV or HIV
4. Patients with a history of thrombotic events and/or at high risk of thrombotic events
5. History of hypersensitivity to IVIg or to any of the excipients
6. Patients unresponsive previously to IVIg or anti-D Ig treatment
7. Patients with immunoglobulin A deficiency and Ab against IgA
10. Received platelets within 7days of Visit 1 and any other blood/plasma product within 1 month of the Baseline Visit (BV)
8. Splenectomy within 4 weeks of the Baseline Visit or planned throughout the study
9. Administration of IVIg, anti-D Ig, Mercaptopurine, Vinca alkaloid, or platelet enhancing drugs within 3 weeks of the Baseline Visit unless patients are on stable treatment as defined. Treatment with any other products licensed for primary chronic ITP is also exclusive.
11. Received recombinant activated factor VII within 7 days rituximab within 6 months of the BV
12 Received live attenuated virus vaccines within 3 months of the BV
13. Use of loop diuretics w/i 1 week of the BV
14. Uncontrolled hypertension
15. Congestive heart failure as per New York Heart Association III/IV, cardiomyopathy, cardiac arrhythmia associated with thromboembolic events , unstable or advanced ischemic heart disease, hyperviscosity
16. Patients with significant protein losing enteropathy, nephrotic syndrome, lymphangiectasia, hyperproteinemia, increased serum viscosity and/or hyponatremia
17. Severe liver or kidney disease
DESCRIPCIÓN
To assess the responder rate of KIg10 in the treatment of adults with chronic ITP by measuring platelet count increase according to the Response (R) definition
PALABRAS CLAVE
antagonistas de la vitamin k, immune thrombocytopenia, vitamin k antagonist
