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New treatment option for Chronic Primary Immune Thrombocytopenia (ITP)
Official title A Study Investigating Intravenous Human Normal Immunoglobulin 10% in Adults With Chronic Immune Thrombocytopenia (ITP)
ClinicalTrials.gov ID: NCT07059000
What this study is testing
What is Kedrion IVIG 10%?
Kedrion IVIG 10% is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for chronic primary immune thrombocytopenia (itp).
Also referred to as KIg 10.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- Male or female, 18-70 years of age.
- Patient has signed the ICF.
- Diagnosis of chronic (\> 12 months duration) ITP as defined by the International Working Group.
- 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...
- A pre-infusion platelet count of \< 30 × 10\^9/L at the Baseline Visit.
You likely can't join if
- Patients incapable of giving informed consent.
- Patients with secondary ITP (all forms of immune-mediated thrombocytopenia except primary ITP). e.g., lupus erythematosus, rheumatoid arthritis...
- Patients with Evans Syndrome.
- Patients known to be infected with hepatitis B virus, hepatitis C virus, or HIV.
- History of thrombotic events including deep vein thrombosis, cerebrovascular accident, pulmonary embolism, transient ischemic attacks, or myocardial...
- Patient with a history of hypersensitivity to IVIg, other injectable forms of IVIg, or to any of the excipients.
See the full eligibility criteria
- Male or female, 18-70 years of age.
- Patient has signed the ICF.
- Diagnosis of chronic (\> 12 months duration) ITP as defined by the International Working Group.
- 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 7 days prior to screening...
- A pre-infusion platelet count of \< 30 × 10\^9/L at the Baseline Visit.
- Patient is willing to comply with all requirements of the protocol.
- Women of childbearing potential (WOCBP) must have a negative urine pregnancy test at screening and agree to employ adequate birth control measures during the study.
- Authorization to access personal health information.
- Patients incapable of giving informed consent.
- 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).
- Patients with Evans Syndrome.
- Patients known to be infected with hepatitis B virus, hepatitis C virus, or HIV.
- History of thrombotic events including deep vein thrombosis, cerebrovascular accident, pulmonary embolism, transient ischemic attacks, or myocardial infarction.
- Patient with a history of hypersensitivity to IVIg, other injectable forms of IVIg, or to any of the excipients.
- Patient unresponsive previously to IVIg or anti-D Ig treatment.
- Patient with known Immunoglobulin A (IgA) deficiency and antibodies against IgA.
- Splenectomy within 4 weeks of the Baseline Visit or planned splenectomy throughout the study period.
- Participants with known inherited thrombocytopenia. e.g., MYH-9 disorders.
- Participants with myelodysplastic syndrome (MDS).
- 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...
- patients on a stable dose of TPO-RA within 4 weeks of the Baseline Visit
- patients on a stable dose of Mycophenolate Mofetil within 3 months of the Baseline Visit
- patients on stable dose of Danazol within 3 months of the Baseline Visit
- 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
- 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. Treatment with...
- Received any blood, blood product, or blood derivative within 1 month of the Baseline Visit.
- Received rituximab within 6 months of the Baseline Visit.
- Had a platelet transfusion or receipt of blood products containing platelets within 7 days of Visit 1 (Day 1).
- Received recombinant activated factor VII within 7 days of the Baseline Visit.
- Had therapy with live attenuated virus vaccines within 3 months of the Baseline Visit.
- Use of loop diuretics within 1 week of the Baseline Visit.
- Patients at high risk of thrombotic events.
- 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...
- 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...
- Patients with significant protein losing enteropathy, nephrotic syndrome, or lymphangiectasia.
- Patients with hyperproteinemia, increased serum viscosity, and/or hyponatremia.
- Severe liver or kidney disease (normal reference ranges of laboratory doing the analysis):
- alanine aminotransferase (ALT) or aspartate amino transferase (AST) 2.5x \> upper limit of normal (ULN)
- creatinine \> 120 μmol/L
- blood urea nitrogen (BUN) \> 2.5x ULN
- 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.
- Body mass index \> 40 kg/m2 or an IVIg dose that puts the patient at risk of fluid overload.
- 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.
- Patient has participated in an treatment, investigational clinical study within 30 days of the Baseline Visit or within 5 half-lives of the investigational medicinal product (IMP) under investigation.
- Any condition that the Investigator believes is likely to interfere with evaluation of the IMP or with satisfactory conduct of the trial.
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- Greenville, North Carolina, United States
- Prague, Prague, Czechia
- Brno, South Moravian, Czechia
- Donauwörth, Bavaria, Germany
- Frankfurt am Main, Hesse, Germany
- Florence, Florence, Italy
- Novara, Novara, Italy
- Trieste, Trieste, Italy
- Torino, Turin, Italy
- Vicenza, Vicenza, Italy
- Bucharest, Bucharest, Romania
- Cluj-Napoca, Cluj, Romania
- Craiova, Dolj, Romania
- Belgrade, Serbia
- Burgos, Burgos, Spain
- A Coruña, La Coruña, Spain
- Madrid, Madrid, Spain
- Ankara, Ankara, Turkey (Türkiye)
- Yenimahalle, Ankara, Turkey (Türkiye)
+ 4 more site(s).
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, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; Greenville, North Carolina, United States; Prague, Prague, Czechia; Brno, South Moravian, Czechia; Donauwörth, Bavaria, Germany; Frankfurt am Main, Hesse, Germany and 18 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.