Kedrion IVIG for Immune Thrombocytopenic Purpura
(ITP Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a treatment called Kedrion IVIG 10% (an intravenous immunoglobulin) to determine its effectiveness for people with chronic primary Immune Thrombocytopenic Purpura (ITP), a condition where the immune system attacks and destroys platelets, causing easy bruising and bleeding. The trial aims to evaluate how well and safely this treatment can increase platelet counts in affected individuals. Participants will receive the treatment over two days and will be monitored for effectiveness and any side effects. This trial suits those who have had chronic ITP for over a year, with consistently low platelet counts impacting their daily life. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment.
Do I have to stop taking my current medications for the trial?
The trial requires that you stop taking certain medications like IVIg, anti-D immunoglobulin, and others within 3 weeks of the Baseline Visit, unless you are on a stable dose of specific medications like TPO-RA, Mycophenolate Mofetil, Danazol, or long-term corticosteroid therapy. It's best to discuss your current medications with the trial team to see if any adjustments are needed.
Is there any evidence suggesting that Kedrion IVIG 10% is likely to be safe for humans?
Research shows that Kedrion IVIG 10% is being tested for its safety and effectiveness in treating chronic primary immune thrombocytopenic purpura (ITP), a condition where low platelet counts prevent proper blood clotting. Previous studies have found that this treatment is generally well-tolerated by patients, with most side effects being mild, such as headaches and nausea, and serious side effects being rare.
The trial's advanced stage indicates that earlier studies have found the treatment to be relatively safe, having already passed initial safety checks in previous research phases. While every medical treatment can have side effects, the evidence so far suggests that Kedrion IVIG 10% is a promising option for people with ITP.12345Why do researchers think this study treatment might be promising?
Kedrion IVIG 10% is unique because it offers a new formulation of intravenous immunoglobulin (IVIG) for treating Immune Thrombocytopenic Purpura (ITP). Unlike standard treatments like corticosteroids or other IVIG options, this specific formulation is administered at a higher concentration, potentially allowing for a quicker and more efficient treatment course over just two days. Researchers are excited about this treatment because it could lead to faster platelet recovery in patients, reducing the risk of bleeding complications more swiftly than current options.
What evidence suggests that Kedrion IVIG 10% might be an effective treatment for ITP?
Research has shown that Kedrion IVIG 10% effectively treats adults with chronic immune thrombocytopenic purpura (ITP), a condition characterized by low platelet counts. This treatment increases platelet levels, reducing the risk of bleeding. The highly purified IVIG 10% enhances safety. Specifically, previous patients demonstrated significant improvements in platelet levels after receiving this treatment. This evidence suggests that Kedrion IVIG 10% could be a viable option for managing chronic ITP.13467
Who Is on the Research Team?
Mirella Calcinai, MD
Principal Investigator
Kedrion S.p.A.
Are You a Good Fit for This Trial?
Adults aged 18-70 with chronic primary Immune Thrombocytopenia (ITP) for over a year, having low platelet counts and willing to follow the study rules. Excludes those with severe liver/kidney disease, certain blood conditions, hypersensitivity to IVIg or its components, recent use of specific drugs or treatments affecting platelets, high risk of clots, heart issues, and other serious health problems.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Subjects receive one course of treatment with 2 g/kg of Kedrion IVIg 10% administered over 2 days
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Kedrion IVIG 10%
Find a Clinic Near You
Who Is Running the Clinical Trial?
Kedrion S.p.A.
Lead Sponsor
ICON plc
Industry Sponsor
Dr. Steve Cutler
ICON plc
Chief Executive Officer since 2017
PhD from the University of Sydney, MBA from the University of Birmingham
Dr. Greg Licholai
ICON plc
Chief Medical Officer since 2023
Degrees from Harvard Business School, Yale School of Medicine, Columbia University, and Boston College