2023-507115-35-00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.16 个研究点 分布在 5 个国家目标入组 24 人开始时间: 2025年4月30日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 24
- 试验地点
- 16
- 主要终点
- The rate of subjects with response (R), defined as subjects with a platelet count > 30 × 109/L and at least a 2-fold increase of the baseline count, confirmed during the evaluation period on at least 2 separate occasions at least 7 days apart, and absence of bleeding during the evaluation period.
研究概览
简要总结
To assess the responder rate of KIg10 in the treatment of adults with chronic ITP by measuring platelet count increase according to the Response (R) definition
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Male or female, 18-70 years of age.
- •Patient and/or legal authorized representative has signed the ICF.
- •Diagnosis of chronic (> 12 months duration) ITP as defined by the International Working Group (Rodeghiero, 2009).
- •Mean screening platelet count of < 30 × 109/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.
- •Platelet count of < 30 × 109/L at the Baseline Visit.
- •Patient is willing to comply with all requirements of the protocol.
- •Women of childbearing potential 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 with secondary ITP
- •Signs of severe anemia
- •BMI > 40 kg/m2 or an IVIg dose that puts the patient at risk of fluid overload
- •Patients with Evans Syndrome, inherited thrombocytopenia, myelodysplastic syndrome
- •History of a malignant disease within 3 years of the Baseline Visit other than 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
- •Patients infected with HBV, HCV or HIV
- •Patients with a history of thrombotic events and/or at high risk of thrombotic events
- •History of hypersensitivity to IVIg or to any of the excipients
- •Patients unresponsive previously to IVIg or anti-D Ig treatment
- •Patients with immunoglobulin A deficiency and Ab against IgA
- •Received platelets within 7days of Visit 1 and any other blood/plasma product within 1 month of the Baseline Visit (BV)
- •Splenectomy within 4 weeks of the Baseline Visit or planned throughout the study
- •Administration of IVIg, anti-D Ig, mercaptopurine, vinca alkaloid, or platelet enhancing drugs within 3 weeks of the Baseline Visit unless patients are on stable treatment
- •Received recombinant activated factor VII within 7 days rituximab within 6 months of the BV
- •12 Received live attenuated virus vaccines within 3 months of the BV
- •Use of loop diuretics w/i 1 week of the BV
- •Uncontrolled hypertension
- •Congestive heart failure as per New York Heart Association III/IV, cardiomyopathy, cardiac arrhythmia associated with thromboembolic events , unstable or advanced ischemic heart disease, hyperviscosity
- •Patients with significant protein losing enteropathy, nephrotic syndrome, lymphangiectasia, hyperproteinemia, increased serum viscosity and/or hyponatremia
- •Severe liver or kidney disease
结局指标
主要结局
The rate of subjects with response (R), defined as subjects with a platelet count > 30 × 109/L and at least a 2-fold increase of the baseline count, confirmed during the evaluation period on at least 2 separate occasions at least 7 days apart, and absence of bleeding during the evaluation period.
The rate of subjects with response (R), defined as subjects with a platelet count > 30 × 109/L and at least a 2-fold increase of the baseline count, confirmed during the evaluation period on at least 2 separate occasions at least 7 days apart, and absence of bleeding during the evaluation period.
次要结局
- 1.Number and rate of subjects with: a.CR: PLT > 100x109/L on 2 occasions at least 7 days apart and no bleeding b. loss of CR or R: PLT <100x109/L or bleeding ( CR) or PLT <30x109/L or < 2-fold increase of baseline or bleeding (R) c.Non-responders (NR)
- 2.Time to response
- 3. Response Duration
- 4. Hemorrhages regression of
- 5. maximum PLT count achieved
- 6.Time to maximum PLT count
- 7.Bleedings (timing/grade)
研究者
Miranda Norton
Scientific
Kedrion S.p.A.
研究点 (16)
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