ACTRN12607000431426招募中1 期
An open label, sequential, dose escalation, repeat-dose study of the safety, pharmacokinetics, pharmacodynamics, and immunogenicity of PRTX-100 in adult patients with chronic Idiopathic Thrombocytopenic Purpura (ITP)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 21
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 -2147483648 No limit（—）
- 性别
- All
入选标准
- •Diagnosis of chronic ITP >4 months
- •Mean platelet count <50x109/L within 30 days prior to study start for patients not receiving corticosteroids; <90x109/L within 30 days prior to study start for patients receiving stable dose of corticosteroids
排除标准
- •Splenectomy within 45 days of screening
- •Clinically significant history or evidence (as determined by the Investigator) of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, neurological, immunological, or psychiatric disorders which would increase risk to the patient in this study
- •Treatment with rituximab within 6 months prior to screening
- •Treatment with cyclophosphamide, vincristine, or any other non-monoclonal antibody treatment for ITP within 3 months prior to screening, with the exception of steroid sparing adjunctive treatment with cyclosporine or azathioprine
- •Treatment with intravenous immunoglobulin (IVIG), WinRho® or other anti-RhD within 30 days prior to screening
研究者
相似试验
进行中（未招募）
1 期
A dose escalation trial to assess the safety and tolerability of multiple doses of the CAN04 antibody, in patients with solid malignant tumors.EUCTR2017-001111-36-NLCantargia AB116
进行中（未招募）
1 期
A dose escalation trial to assess the safety and tolerability of multiple doses of the CAN04 antibody, in patients with solid malignant tumors.EUCTR2017-001111-36-DKCantargia196
进行中（未招募）
1 期
A dose escalation trial to assess the safety and tolerability of multiple doses of the CAN04 antibody, in patients with solid malignant tumors.EUCTR2017-001111-36-DECantargia AB196
进行中（未招募）
1 期
A dose escalation trial to assess the safety and tolerability of multiple doses of the CAN04 antibody, in patients with solid malignant tumors.EUCTR2017-001111-36-ATCantargia AB116
进行中（未招募）
1 期
A dose escalation trial to assess the safety and tolerability of multiple doses of the CAN04 antibody, in patients with solid malignant tumors.Solid malignant tumors, in the following four indicationsNon-Small Cell Lung Cancer (NSCLC), Pancreatic Ductal Adenocarcinoma (PDAC), Triple negative Breast Cancer (TNBC) orColorectal Cancer (CRC)MedDRA version: 21.1Level: LLTClassification code 10065147Term: Malignant solid tumorSystem Organ Class: 100000004864EUCTR2017-001111-36-NOCantargia116