RECRUITING

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

Conditions

Chronic Primary Immune Thrombocytopenia (ITP)ITP Primary Immune Thrombocytopenia Autoimmune Disease Hemorrhagic Disorders Hematologic Diseases Blood Coagulation Disorders

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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)

Quick Facts

Study Start:2025-08-13

Study Completion:2026-08

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT07059000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 70 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
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 × 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 14 days prior to the first KIg10 infusion. The second qualifying count will be measured within 7 days before the first KIg10 infusion. 5. 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 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.	1. 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). 2. Patients with Evans Syndrome. 3. Patients known to be infected with hepatitis B virus, hepatitis C virus, or HIV. 4. History of thrombotic events including deep vein thrombosis, cerebrovascular accident, pulmonary embolism, transient ischemic attacks, or myocardial infarction. 5. Patient with a history of hypersensitivity to IVIg, other injectable forms of IVIg, or to any of the excipients. 6. Patient unresponsive previously to IVIg or anti-D Ig treatment. 7. Patient with known Immunoglobulin A (IgA) deficiency and antibodies against IgA. 8. Splenectomy within 4 weeks of the Baseline Visit or planned splenectomy throughout the study period. 9. Subjects with known inherited thrombocytopenia. e.g., MYH-9 disorders. 10. Subjects with myelodysplastic syndrome (MDS). 11. 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. 12. Received any blood, blood product, or blood derivative within 1 month of the Baseline Visit. 13. Received rituximab within 6 months of the Baseline Visit. 14. Had a platelet transfusion or receipt of blood products containing platelets within 7 days of Visit 1 (Day 1). 15. Received recombinant activated factor VII within 7 days of the Baseline Visit. 16. Had therapy with live attenuated virus vaccines within 3 months of the Baseline Visit. 17. Use of loop diuretics within 1 week of the Baseline Visit. 18. Patients at high risk of thrombotic events. 19. 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. 20. 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. 21. Patients with significant protein losing enteropathy, nephrotic syndrome, or lymphangiectasia. 22. Patients with hyperproteinemia, increased serum viscosity, and/or hyponatremia. 23. 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 2. creatinine \> 120 μmol/L 3. blood urea nitrogen (BUN) \> 2.5x the upper limit of normal. 24. 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. 25. Body mass index \> 40 kg/m2 or an IVIg dose that puts the patient at risk of fluid overload. 26. 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. 27. Patient has participated in an interventional, investigational clinical study within 30 days of the Baseline Visit. 28. Any condition that the Investigator believes is likely to interfere with evaluation of the study drug or with satisfactory conduct of the trial.

Inclusion Criteria

Exclusion Criteria

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 × 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 14 days prior to the first KIg10 infusion. The second qualifying count will be measured within 7 days before the first KIg10 infusion.
5. 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 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.

1. 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).
2. Patients with Evans Syndrome.
3. Patients known to be infected with hepatitis B virus, hepatitis C virus, or HIV.
4. History of thrombotic events including deep vein thrombosis, cerebrovascular accident, pulmonary embolism, transient ischemic attacks, or myocardial infarction.
5. Patient with a history of hypersensitivity to IVIg, other injectable forms of IVIg, or to any of the excipients.
6. Patient unresponsive previously to IVIg or anti-D Ig treatment.
7. Patient with known Immunoglobulin A (IgA) deficiency and antibodies against IgA.
8. Splenectomy within 4 weeks of the Baseline Visit or planned splenectomy throughout the study period.
9. Subjects with known inherited thrombocytopenia. e.g., MYH-9 disorders.
10. Subjects with myelodysplastic syndrome (MDS).
11. 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.
12. Received any blood, blood product, or blood derivative within 1 month of the Baseline Visit.
13. Received rituximab within 6 months of the Baseline Visit.
14. Had a platelet transfusion or receipt of blood products containing platelets within 7 days of Visit 1 (Day 1).
15. Received recombinant activated factor VII within 7 days of the Baseline Visit.
16. Had therapy with live attenuated virus vaccines within 3 months of the Baseline Visit.
17. Use of loop diuretics within 1 week of the Baseline Visit.
18. Patients at high risk of thrombotic events.
19. 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.
20. 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.
21. Patients with significant protein losing enteropathy, nephrotic syndrome, or lymphangiectasia.
22. Patients with hyperproteinemia, increased serum viscosity, and/or hyponatremia.
23. 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
2. creatinine \> 120 μmol/L
3. blood urea nitrogen (BUN) \> 2.5x the upper limit of normal.
24. 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.
25. Body mass index \> 40 kg/m2 or an IVIg dose that puts the patient at risk of fluid overload.
26. 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.
27. Patient has participated in an interventional, investigational clinical study within 30 days of the Baseline Visit.
28. Any condition that the Investigator believes is likely to interfere with evaluation of the study drug or with satisfactory conduct of the trial.

Contacts and Locations

Study Contact

Anna Lotti Suffredini

CONTACT

+39 338 6827568

a.lotti@kedrion.com

Linda Karpiak

CONTACT

973-216-0484

l.karpiak@kedrion.com

Principal Investigator

Mirella Calcinai, MD

STUDY_DIRECTOR

Kedrion S.p.A.

Study Locations (Sites)

University of Southern California

Los Angeles, California, 90033

United States

East Carolina University

Greenville, North Carolina, 27834

United States

Collaborators and Investigators

Sponsor: Kedrion S.p.A.

Mirella Calcinai, MD, STUDY_DIRECTOR, Kedrion S.p.A.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-08-13

Study Completion Date2026-08

Study Record Updates

Study Start Date2025-08-13

Study Completion Date2026-08

Terms related to this study

Keywords Provided by Researchers

ITP
Primary Immune Thrombocytopenia
Autoimmune Disease
Hemorrhagic Disorders
Hematologic Diseases
Blood Coagulation Disorders

Additional Relevant MeSH Terms

Chronic Primary Immune Thrombocytopenia (ITP)