MONOCLONAL ANTIBODY FOR CHRONIC ITP

慢性 ITP 的单克隆抗体

• 批准号: 6275328
• 负责人: DAVID GREEN
• 金额: $ 2.26万
• 依托单位: NORTHWESTERN UNIVERSITY AT CHICAGO
• 依托单位国家: 美国
• 财政年份: 1997
• 资助国家: 美国
• 起止时间: 1997-12-01 至 1998-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6275328
• 关键词: chronic disease /disorder; clinical research; clinical trials; dosage; human subject; human therapy evaluation; immunoglobulins; immunotherapy; lymphocyte; monoclonal antibody; thrombocytopenic purpura

This multicenter, randomized, double-blind, controlled, dose-escalation study will evaluate a humanized monoclonal antibody in patients with chronic refractory immune thrombocytopenic purpura. The antibody alters the ability of T-cells to stimulate B-cells to make autoimmune antibodies. A single 30 min IV infusion will be given to patients with ITP who have failed steroid and splenectomy therapy. Subjects will be randomized to receive escalating doses of antibody based on the results from previous lower doses. Pharmacokinetic data will be recorded as well as platelet counts and levels of anti-platelet antibody, phenotypes of peripheral blood lymphocytes and levels of serum immunoglobulins. Should the antibody prove safe and effective, future trials are planned involving a larger number of subjects.

这个多中心，随机，双盲，受控，剂量升级 研究将评估人源化的单克隆抗体 慢性耐火免疫血小板减少性紫癜。抗体改变 T细胞刺激B细胞制造自身免疫性抗体的能力。 ITP患者将进行一次30分钟的IV输注 类固醇和脾切除术失败。受试者将被随机分为 根据先前的结果，接受抗体的升级剂量 较低剂量。将记录药代动力学数据以及血小板 抗血小板抗体的计数和水平，外周血的表型 淋巴细胞和血清免疫球蛋白水平。抗体应该证明 安全有效的未来试验计划涉及更多数量 主题。