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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-13

Study Completion Date

2026-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

This Clinical Study is to Test Efficacy and Safety of BT595 in Chronic Primary Immune Thrombocytopenia (ITP)

NCT02859909

Immune Thrombocytopenia

COMPLETED PHASE3

An Open-label Study of Intravenous Immunoglobulin (5%) for the Treatment of Primary Immune Thrombocytopenia

NCT07233213

Primary Immune Thrombocytopenia (ITP)

RECRUITING PHASE3

The ITP-RITUX Cohort: Rituximab in Immune ThrombocytoPenia.

NCT01101295

Purpura, Thrombocytopenic, Idiopathic Autoimmune Thrombocytopenia

UNKNOWN

Efficacy and Safety Study of a 10% Triple Virally Reduced Intravenous Immune Globulin Solution in Adult Subjects With Chronic Idiopathic Thrombocytopenic Purpura

NCT00162006

Immune Thrombocytopenic Purpura (ITP)

COMPLETED PHASE2

Iguratimod Plus Low-dose Rituximab vs Low-dose Rituximab in Corticosteroid-resistant or Relapsed ITP

NCT07057778

Immune Thrombocytopenia (ITP)

NOT_YET_RECRUITING PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Primary Immune Thrombocytopenia (ITP)

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

2 g/kg Kedrion IVIg 10%

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

Group Type EXPERIMENTAL

Kedrion IVIG 10%

Intervention Type BIOLOGICAL

(Intravenous) Human Normal Immunoglobulin (IVIg) 10%

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Kedrion IVIG 10%

(Intravenous) Human Normal Immunoglobulin (IVIg) 10%

Intervention Type BIOLOGICAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

KIg 10

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No