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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)
EU CTIS ID: 2023-507115-35-00
What this study is testing
To assess the responder rate of KIg10 in the treatment of adults with chronic ITP by measuring platelet count increase according to the Response (R) definition
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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 × 109/L from two qualifying counts measured at least one calendar day apart. The first qualifying count can be from historical data if measured within 7 days prior to the screening. The second qualifying count will be measured within 7 days before the first KIg10 infusion.
- 5. Platelet count of < 30 × 109/L at the Baseline Visit.
- 6. Patient is willing to comply with all requirements of the protocol.
You likely can't join if
- 1. Patients with secondary ITP
- 18. Signs of severe anemia
- 19. BMI > 40 kg/m2 or an IVIg dose that puts the patient at risk of fluid overload
- 2. Patients with Evans Syndrome, inherited thrombocytopenia, myelodysplastic syndrome
- 20. History of a malignant disease within 3 years of the Baseline Visit other than treated carcinoma in situ of the cervix or basal cell or squamous cell carcinoma of the skin
- 21. Patient has participated in an interventional, investigational clinical study within 30 days of the Baseline Visit
See the full eligibility 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 × 109/L from two qualifying counts measured at least one calendar day apart. The first qualifying count can be from historical data if measured within 7 days prior to the screening. The second qualifying count will be measured within 7 days before the first KIg10 infusion.
- 5. Platelet count of < 30 × 109/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
- 18. Signs of severe anemia
- 19. BMI > 40 kg/m2 or an IVIg dose that puts the patient at risk of fluid overload
- 2. Patients with Evans Syndrome, inherited thrombocytopenia, myelodysplastic syndrome
- 20. History of a malignant disease within 3 years of the Baseline Visit other than treated carcinoma in situ of the cervix or basal cell or squamous cell carcinoma of the skin
- 21. Patient has participated in an interventional, investigational clinical study within 30 days of the Baseline Visit
- 3. Patients infected with HBV, HCV or HIV
- 4. Patients with a history of thrombotic events and/or at high risk of thrombotic events
- 5. History of hypersensitivity to IVIg or to any of the excipients
- 6. Patients unresponsive previously to IVIg or anti-D Ig treatment
- 7. Patients with immunoglobulin A deficiency and Ab against IgA
- 10. Received platelets within 7days of Visit 1 and any other blood/plasma product within 1 month of the Baseline Visit (BV)
- 8. Splenectomy within 4 weeks of the Baseline Visit or planned throughout the study
- 9. Administration of IVIg, anti-D Ig, Mercaptopurine, Vinca alkaloid, or platelet enhancing drugs within 3 weeks of the Baseline Visit unless patients are on stable treatment as defined. Treatment with any other products licensed for primary chronic ITP is also exclusive.
- 11. Received recombinant activated factor VII within 7 days rituximab within 6 months of the BV
- 12 Received live attenuated virus vaccines within 3 months of the BV
- 13. Use of loop diuretics w/i 1 week of the BV
- 14. Uncontrolled hypertension
- 15. Congestive heart failure as per New York Heart Association III/IV, cardiomyopathy, cardiac arrhythmia associated with thromboembolic events , unstable or advanced ischemic heart disease, hyperviscosity
- 16. Patients with significant protein losing enteropathy, nephrotic syndrome, lymphangiectasia, hyperproteinemia, increased serum viscosity and/or hyponatremia
- 17. Severe liver or kidney disease
The study team makes the final eligibility decision.
Where it's taking place
- United States
- Turkey
- Serbia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States; Turkey; Serbia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.