NCT07059000 · Kedrion S.p.A.
A Study Investigating Intravenous Human Normal Immunoglobulin 10% in Adults With Chronic Immune Thrombocytopenia (ITP)
(ITP)
What this study is about
The purpose of this study is to evaluate the effectiveness and safety of KIg 10 (given through a vein (IV) Immunoglobulin 10%) in adult patients with chronic primary ITP
View original scientific description
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
Interventions
BIOLOGICAL
Kedrion IVIG 10%
(Intravenous) Human Normal Immunoglobulin (IVIg) 10%
Primary outcome measures
Rate of subjects with response (R)
Time frame: 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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
- Patients with secondary ITP (all forms of immune-mediated thrombocyto
Where
- Los Angeles, California
- Greenville, North Carolina
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 16, 2026 · Source of record for eligibility and locations