ACTRN12606000459527终止1 期
A Phase I Open-Label, Single Dose, Dose Escalation Study to investigate the safety and tolerability of KB002, a Chimeric Monoclonal Antibody Which Binds to GM-CSF (Granulocyte Macrophage Colony Stimulating Factor), in Patients with Chronic Idiopathic Thrombocytopenia Purpura (ITP)
KaloBios Pharmaceuticals Inc0 个研究点目标入组 27 人开始时间: 2006年11月2日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 27
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 ot stated（—）
- 性别
- All
入选标准
- •1. Willing and able to give written informed consent 2. Chronic idiopathic thrombocytopenic purpura (ITP) for at least 6 months 3. Platelet count <30 x 109/L for patients not receiving corticosteroids; < 50 x 109/L for patients receiving a stable dose of corticosteroids (i.e., the dose has not increased or decreased within 4 weeks of Day 1).
排除标准
- •1. Treatment with cyclophosphamide, vincristine, rituximab, any other monoclonal antibody or an investigational drug within 12 weeks of Day 12. Treatment with intravenous immunoglobulin (IVIG) or intravenous Rh(D) immune globulin within 4 weeks of Day 13. Treatment with any other agent for the treatment of ITP within 4 weeks of Day 1, other than a stable dose of corticosteroids (i.e., the dose has not increased or decreased within 4 weeks of Day 1)4. Vaccination within 4 weeks of Day 15. Any of the following laboratory parameters:• WBC = 3.5 x 109/L or neutrophil count = 2.0 x 109/L• Creatinine = 2 mg/dL• Total bilirubin = 2 mg/dL• Alanine transaminase (ALT) and/or aspartate transaminase (AST) = 3 times the upper limit of normal (ULN)6. PaO2 = 95% on room air by pulse oximetry7. Major surgery, including splenectomy, within 8 weeks of Day 18. Females who are pregnant or breastfeeding9. Males or females unable to practice effective methods of birth control for 3 months after the infusion of study drug10. Current or past history of severe cardiac disease (NYHA grade III or IV, defined in Appendix B)11. Current respiratory disease or a past history of chronic respiratory disease12. Active hemolysis that requires red blood cell transfusion within 6 weeks of study entry13. History of drug-induced thrombocytopenia, marrow failure syndrome, such as aplastic anemia or myelodysplasia, or thrombocytopenia related to viral or bacterial infection14. Immune deficiency, chronic infection or chronic inflammatory condition (e.g., positive for hepatitis B surface antigen [HBsAg], hepatitis C virus [HCV] or human immunodeficiency virus [HIV], history of tuberculosis [TB], or systemic lupus erythematosus [SLE])15. History of solid or hematologic malignancy in the past 10 years, other than basal cell or non invasive squamous cell carcinoma16. Any other illness or condition that in the opinion of the investigator would be considered a high risk for participation in an investigational study, such as uncontrolled and/or clinically significant neurologic, hematologic, metabolic, endocrine, gastrointestinal, hepatic or renal disease.
研究者
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