NCT00511147已完成3 期
A Multi-center, Prospective, Open-label, Clinical Trial to Assess the Safety and the Efficacy of a New Intravenous Immune Globulin (IGIV3I Grifols 10%) in Patients With Idiopathic (Immune) Thrombocytopenic Purpura
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 88
- 主要终点
- Response Rate
研究概览
简要总结
Idiopathic (immune) thrombocytopenic purpura (ITP) is an autoimmune disorder characterized by platelet destruction and thrombocytopenia (peripheral blood platelet count < 150 x 10^9/L). IVIG therapy is useful in patients in whom the platelet count has to be raised either due to bleeding signs, or where bleeding is predicted (e.g., surgery or parturition). The primary goal of treatment is to maintain the platelet count at a hemostatic level. This study will test the safety and efficacy of IGIV3I Grifols 10% in the treatment of patients with chronic 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
- 3 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of chronic ITP
- •Platelet count ≤ 20 x 10^9/L
- •When administered corticosteroids at any time within 3 weeks before screening visit, the subject must have completed at least 3 weeks (21 days) of therapy at a stable and constant dose and schedule prior to screening visit
- •When administered azathioprine (immunosuppressant) at any time within 3 months before screening visit, the subject must have received a stable dose and schedule for at least 3 months prior to screening visit
- •When administered vinca alkaloids (eg., vincristine) at any time within 2 weeks before screening visit, the subject must have received a stable dose and schedule for at least 2 weeks prior to screening visit
- •When administered attenuated androgens (eg, danazol) at any time within 8 weeks before screening visit, the subject must have received a stable dose and schedule for at least 8 weeks prior to screening visit.
- •Females of childbearing potential must test negative for pregnancy
排除标准
- •History or clinical evidence of medical conditions (other than ITP) felt to be the underlying cause of the thrombocytopenia
- •Diagnosis of secondary immune thrombocytopenia
- •History of severe (eg, anaphylactic) reactions to blood or any blood- derived product
- •History of intolerance to any component of the IP, such as sorbitol
- •Suffering serious and/or life-threatening hemorrhage/bleeding defined as:
- •Any intracranial or central nervous system bleeding
- •Any hemorrhagic event in which the subject is at risk of death at the time of the event
- •Females who are pregnant or nursing an infant child
- •Known to have immunoglobulin A (IgA) deficiency
- •Known to abuse alcohol, opiates, psychotropic agents or other chemicals or drugs, or has done so within 12 months of the screening visit
- •Documented diagnosis of thrombotic complications to polyclonal IVIG therapy in the past
- •Unstable or uncontrolled disease, or condition, related to, or impacting, cardiac function: unstable angina, congestive heart failure, uncontrolled arterial hypertension
- •Is anemic (hemoglobin < 9 g/dL)
- •Renal impairment (ie, serum creatinine > 1.5 x upper limit of normal [ULN])
- •Aspartate aminotransferase or alanine aminotransferase levels > 2.5 x ULN
- •Known to have a positive test for either HCV or HIV (HIV 1/2)
- •Splenectomy within the prior 8 weeks to the screening visit
- •currently receiving any treatment for ITP except corticosteroids, azathioprine, vinca alkaloids or danazol
- •Received an immune serum globulin (ISG) product within the prior 3 weeks (21 days) to the screening visit
- •Received any alkylating agent (eg, cyclophosphamide) within 5 weeks prior to the screening visit
- •Received rituximab within the prior 3 months to the screening visit
- •Was currently receiving, or received, any therapeutic drug or device that was not approved by a Regulatory Authority (US or Canadian) for any indication within the prior 12 weeks to the screening visit
结局指标
主要结局
Response Rate
时间窗: 8 days
Defined by the percentage of treated patients in whom platelet counts increase from ≤ 20 x 10\^9/L to ≥ 50 x 10\^9/L by Day 8 ± 1 \[where the day of the first infusion is Day 1\]
次要结局
- Regression of Hemorrhage/Bleedings(15 days)
- Time to Platelet Count Recovery(30 days)
- Duration of Response(30 days)
研究者
研究点 (88)
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