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

Kedrion Biopharma

Status and phase

Enrolling

Phase 3

Conditions

Chronic Primary Immune Thrombocytopenia (ITP)

Treatments

Biological: Kedrion IVIG 10%

Study type

Interventional

Funder types

Industry

Identifiers

NCT07059000

KB072

2023-507115-35-00 (EU Trial (CTIS) Number)

Details and patient eligibility

About

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

Enrollment

40 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Male or female, 18-70 years of age.
Patient and/or legal authorized representative 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 14 days prior to the first KIg10 infusion. The second qualifying count will be measured within 7 days before the first KIg10 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 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.

Exclusion criteria

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.
Subjects with known inherited thrombocytopenia. e.g., MYH-9 disorders.
Subjects 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:
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.
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.
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.
Patients with significant protein losing enteropathy, nephrotic syndrome, or lymphangiectasia.
Patients with hyperproteinemia, increased serum viscosity, and/or hyponatremia.
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.
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.
Body mass index > 40 kg/m2 or an IVIg dose that puts the patient at risk of fluid overload.
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.
Patient has participated in an interventional, investigational clinical study within 30 days of the Baseline Visit.
Any condition that the Investigator believes is likely to interfere with evaluation of the study drug or with satisfactory conduct of the trial.