NCT00162006已完成2 期
Prospective Open-Label Study of the Efficacy and Safety of Immune Globulin Intravenous (Human), 10% TVR Solution in Adult Subjects With Chronic Idiopathic Thrombocytopenic Purpura
Baxalta now part of Shire11 个研究点 分布在 4 个国家目标入组 28 人开始时间: 2003年1月13日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 28
- 试验地点
- 11
- 主要终点
- Subjects Who Qualify As Treatment Responders
研究概览
简要总结
The purpose of this study is to evaluate whether Immune Globulin Intravenous (Human), 10% TVR (Triple Virally Reduced) Solution is an effective and safe treatment in patients with chronic idiopathic thrombocytopenic purpura.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >= 18 and <= 65 years
- •ITP diagnosed at least 6 months prior to study entry by history, physical exam, blood count and blood smear
- •Baseline platelet count of <= 20 x 10 to the 9th/L determined prior to administration of the study drug on the day of the first infusion
- •No IVIG treatment for ITP during the two weeks prior to the first infusion of the study drug
- •For females of child bearing potential, use of adequate birth control measures during study participation
- •Written informed consent
排除标准
- •Serum values of ALT, AST, alkaline phosphatase, and total bilirubin exceeding 2.5 times the upper limit of normal at screening
- •Renal dysfunction defined as serum creatinine greater than or equal to 2 mg/dL at screening
- •Underlying other autoimmune or lymphoproliferative disorder
- •Uncontrolled hypertension
- •Cardiac insufficiency NYHA III and IV, coronary heart disease (CHD) NYHA III and IV
- •Malignancy or history of malignancy
- •Documented selective IgA deficiency (<= 10 mg/dL)
- •Treatment with another investigational drug in the four weeks prior to study entry or current treatment with another investigational product
- •History of severe adverse reactions to blood and/or blood products
- •Pregnancy or lactation
- •Positivity for HIV, or HCV antibodies, or HBsAg
- •History of unresponsiveness to IVIG defined as a peak increment in platelet count <= 20,000/µL coincident with the last IVIG treatment course prior to study entry
结局指标
主要结局
Subjects Who Qualify As Treatment Responders
时间窗: Baseline thru Day 15 post treatment
Subjects who i) had at least one platelet count of ≥50 x 109/L prior to Day 15 and ii) did not require a booster dose prior to Day 15, where Day 15 refers to the fifteenth day after initiation of treatment (Day 1). Otherwise, the subject is a non-responder.
次要结局
- Time to achieve a platelet count > 50 x 109/L(Day 29 (study termination visit))
- Duration of platelet response(Day 29 (study termination visit))
- Number of Adverse Experiences(Throughout the study period of approximately 11 months)
- Maximum Platelet Count(Day 29 (study termination visit))
研究者
研究点 (11)
Loading locations...
相似试验
已完成
2 期
Rapid Infusion Of Immune Globulin Intravenous (IGIV) In Patients With ITPPurpura, Thrombocytopenic, IdiopathicNCT00220727Grifols Therapeutics LLC8
已完成
3 期
Open Label, Phase III Study of NABI-IGIV 10% [Immune Globulin Intravenous(Human), 10%] In Subjects With Primary Immune Deficiency Disorders (PIDD)Primary Immune Deficiency Disorders (PIDD)NCT00538915ADMA Biologics, Inc.63
撤回
3 期
Intravenous Immunoglobulins in Complex-regional Pain SyndromeComplex Regional Pain Syndrome Type 1NCT00949065University of Giessen
已完成
1 期
Use of Immune Globulin Plus Rituximab for Desensitization in Highly HLA Sensitized Patients Awaiting Deceased Donor Kidney TransplantationEnd Stage Renal DiseaseNCT01178216Stanley Jordan, MD41
已完成
3 期
Safety and Efficacy Study of a 10% Intravenous Immune Globulin Solution in Subjects With Primary Immunodeficiency DisordersPrimary Immunodeficiency Diseases (PID)Immune Thrombocytopenic Purpura (ITP)Kawasaki SyndromeNCT00157079Baxalta now part of Shire61