NCT07059000招募中3 期
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)
Kedrion S.p.A.44 个研究点 分布在 8 个国家目标入组 40 人开始时间: 2025年8月13日最近更新:
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 44
- 主要终点
- Rate of subjects with response (R)
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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. The second qualifying count will be measured within 7 days before the first KIg10 infusion.
- •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.
排除标准
- •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 3 weeks of the Baseline Visit, except for:
- •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 any other products licensed for primary chronic ITP is also exclusive. An appropriate wash-out period must be determined in case of patients who might be eligible for treatment with IVIg.
- •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 the three measurements used.
- •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, hyperviscosity.
- •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 interventional, 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.
研究组 & 干预措施
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
干预措施: Kedrion IVIG 10% (Biological)
结局指标
主要结局
Rate of subjects with response (R)
时间窗: 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
Rate of subjects with response (R)
时间窗: 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
次要结局
- Number and rate of subjects with complete response (CR)(Treatment to day 14)
- Time to platelet count response(Treatment to day 14)
- Duration of response(14 days after treatment to end of study)
- Regression of hemorrhages(Day 1 (Visit 1) to Day 30 (End of Study Visit))
- Platelet count assessment(Day 1 (Visit 1) to Day 30 (End of Study Visit))
- Assess safety and tolerability(Day 1 (Visit 1) to Day 30 (End of Study Visit))
- Number and rate of subjects with complete response (CR)(Treatment to day 14)
- Time to platelet count response(Treatment to day 14)
- Duration of response(14 days after treatment to end of study)
- Regression of hemorrhages(Day 1 (Visit 1) to Day 30 (End of Study Visit))
- Platelet count assessment(Day 1 (Visit 1) to Day 30 (End of Study Visit))
- Assess safety and tolerability(Day 1 (Visit 1) to Day 30 (End of Study Visit))
研究者
研究点 (44)
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