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Kedrion IVIG 10% · 1 trial · 1 indication
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
| Arm | Type | Description |
|---|---|---|
| 2 g/kg Kedrion IVIg 10% | EXPERIMENTAL | Subjects will receive one course of treatment with 2 g/kg of Kedrion IVIg 10% administered over 2 days |
| Name | Type | Description |
|---|---|---|
| Kedrion IVIG 10% | BIOLOGICAL | (Intravenous) Human Normal Immunoglobulin (IVIg) 10% |
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...
Kedrion IVIG 10% is an investigational intravenous human normal immunoglobulin being studied for the treatment of chronic primary immune thrombocytopenia (ITP) in adults. It is currently in Phase 3 clinical development and has not been approved by regulatory authorities.
Kedrion IVIG 10% is a monoclonal antibody modality, though its specific molecular target is not disclosed. It is an intravenous human normal immunoglobulin product intended to modulate the immune system in chronic primary immune thrombocytopenia (ITP).
Kedrion IVIG 10% is being developed by Icon Plc, a company listed on the stock exchange under the ticker ICLR. The drug is currently in Phase 3 clinical trials for chronic primary immune thrombocytopenia (ITP).
Kedrion IVIG 10% is in Phase 3 clinical development. It is an investigational drug and has not yet received FDA approval. The ongoing Phase 3 trial is recruiting participants with chronic primary immune thrombocytopenia (ITP).
Kedrion IVIG 10% is being studied in one active Phase 3 clinical trial, NCT07059000, titled 'A Study Investigating Intravenous Human Normal Immunoglobulin 10% in Adults With Chronic Immune Thrombocytopenia (ITP)'. The trial is recruiting 40 participants across multiple countries including the United States, Czechia, Germany, Italy, Romania, Serbia, Spain, and Turkey.
Kedrion IVIG 10% is a specific intravenous human normal immunoglobulin 10% product. While it belongs to the class of IVIG therapies, it is a distinct investigational product being developed for chronic primary immune thrombocytopenia (ITP) and is not identified as the same as any other named IVIG product.