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

Not Applicable

Not yet recruiting

• Conditions: Chronic Primary Immune Thrombocytopenia (ITP)
• Interventions: Biological: Kedrion IVIG 10%

• Registration Number: NCT07059000
• Lead Sponsor: Kedrion S.p.A.

Brief 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

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-18
• Study First Submitted QC: 2025-06-30
• Study Start: 2025-07-01
• Study First Posted: 2025-07-10
• Last Update Submitted: 2025-07-21
• Last Update Posted: 2025-07-24
• Primary Completion: 2026-08
• Study Completion: 2026-08-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
2 g/kg Kedrion IVIg 10%	Kedrion IVIG 10%	Subjects will receive one course of treatment with 2 g/kg of Kedrion IVIg 10% administered over 2 days

Primary Outcome Measures

Name	Time	Method
Rate of subjects with response (R)	Treatment to day 14	Assess the responder rate by measuring the platelet count increase according to the Response (R) definition and the absence of bleeding during the evaluation period

Secondary Outcome Measures

Name	Time	Method
Number and rate of subjects with complete response (CR)	Treatment to day 14	Assess the clinical response rate by measuring the platelet count increase and absence of bleeding according to the Complete Response (CR)
Time to platelet count response	Treatment to day 14	Assess the time from starting treatment to time of achievement of CR or R
Duration of response	14 days after treatment to end of study	Measured from achievement of CR or R to loss of CR or R
Regression of hemorrhages	Day 1 (Visit 1) to Day 30 (End of Study Visit)	Time to stop bleedings
Platelet count assessment	Day 1 (Visit 1) to Day 30 (End of Study Visit)	Assess the maximum platelet count and time to achieve the maximum platelet count
Assess safety and tolerability	Day 1 (Visit 1) to Day 30 (End of Study Visit)	Number and percentage of all adverse events (AEs) and serious adverse events (SAEs)

Trial Locations

Locations (27)

University of Southern California; 🇺🇸 Los Angeles, California, United States

East Carolina University; 🇺🇸 Greenville, North Carolina, United States

Vseobecna Fakultni Nemocnice v Praze; 🇨🇿 Praha 2, Prague, Czechia

Fakultni Nemocnice Brno; 🇨🇿 Brno, South Moravian, Czechia

Onkologisches Zentrum Donauwörth Neudegger - Onkomedeor Onkologische Zentren; 🇩🇪 Donauwörth, Bayern, Germany

Universitätsklinikum Frankfurt; 🇩🇪 Frankfurt, Hessen, Germany

Azienda Ospedaliero - Universitaria Careggi; 🇮🇹 Firenze, Florence, Italy

Azienda Ospedaliero-Universitaria Citta della Salute e della Scienza di Torino; 🇮🇹 Torino, Turin, Italy

Azienda Ospedaliero-Universitaria Maggiore della Carità di Novara; 🇮🇹 Novara, Italy

Azienda Sanitaria Universitaria Giuliano Isontina; 🇮🇹 Trieste, Italy

Scroll for more (17 remaining)