Home › Trials › NCT07059000

Intravenous 10% Human Immunoglobulin (KIg10) for Adults with Chronic ITP

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)

PHASE3 · Kedrion S.p.A. · NCT07059000

This trial will test whether KIg10 (intravenous human normal immunoglobulin 10%) can raise platelet counts and is safe for adults with chronic primary ITP who have low platelets.

Quick facts

PhasePHASE3
Study typeInterventional
Enrollment40 (estimated)
Ages18 Years to 70 Years
SexAll
SponsorKedrion S.p.A. (industry)
Drugs / interventionsrituximab, cyclophosphamide
Locations27 sites (Los Angeles, California and 26 other locations)
Trial IDNCT07059000 on ClinicalTrials.gov

What this trial studies

This is a Phase 3 interventional trial of KIg10 (IVIG 10%) in adults aged 18–70 with chronic primary immune thrombocytopenia (ITP) of more than 12 months' duration and baseline platelet counts below 30 × 10^9/L. Eligible participants must have two qualifying low platelet counts (one may be recent historical) and will receive intravenous KIg10 according to the protocol. The study will track platelet count responses and monitor adverse events to characterize efficacy and safety. The trial is sponsored by Kedrion S.p.A. with ICON plc as a collaborator and is being conducted at multiple sites including centers in Los Angeles, Greenville (NC), and Prague.

Who should consider this trial

Good fit: Adults aged 18–70 with chronic primary ITP lasting more than 12 months and platelet counts persistently below 30 × 10^9/L who can give informed consent and follow study procedures are the intended participants.

Not a fit: Patients with secondary forms of ITP, platelet counts at or above 30 × 10^9/L, those outside the 18–70 age range, or with contraindications to IVIG are unlikely to benefit from this trial.

Why it matters

Potential benefit: If successful, KIg10 could increase platelet counts and reduce bleeding risk for adults with chronic ITP.

How similar studies have performed: Intravenous immunoglobulin has a well-established history of temporarily raising platelet counts in ITP, though product-specific Phase 3 data for KIg10 are what this trial aims to generate.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion 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.

Exclusion Criteria:

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.

Where this trial is running

Los Angeles, California and 26 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Chronic Primary Immune Thrombocytopenia, ITP, Primary Immune Thrombocytopenia, Autoimmune Disease, Hemorrhagic Disorders, Hematologic Diseases, Blood Coagulation Disorders

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.