JPRN-UMIN000014816已完成未知
A Multicenter study of the safety and efficacy of Asfotase Alfa (ALXN1215) (Human Recombinant Tissue Nonspecific Alkaline Phosphatase Fusion Protein) in patients with hypophosphatasia (HPP) - Safety and efficacy of Asfotase Alfa in patients with hypophosphatasia (HPP)
HPP study group0 个研究点目标入组 20 人开始时间: 2014年8月11日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- ot applicable 至 ot applicable（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •Patients will be excluded from enrollment in this study if they meet any of the following exclusion criteria: 1. Current evidence of treatable form of rickets 2. Serum calcium or phosphate levels below the normal range 3. Pregnant women and nursing mothers 4. Patient who cannot enforce suitable contraceptive measures during the clinical trial 5. Prior treatment with bisphosphonates Treatment with an investigational drug within 1 month prior to the start of asfotase alfa treatment 7. Current enrollment in any other study involving an investigational new drug, device or treatment for HPP (e.g., bone marrow transplantation) 8. Clinically significant disease that precludes study participation, in the opinion of the Investigator
研究者
相似试验
已完成
不适用
A multi-center study of the safety and efficacy of the percutaneous transvenous mitral annuloplasty system to reduce mitral valve regurgitation in patients with heart failure.mitral regurgitationmitral valve leakage10046973NL-OMON33252Viacor Inc.14
进行中（未招募）
不适用
A Multicenter study on the efficacy and safety of Vivaglobin in Previously Untreated Patients (PUPs) with Primary Immunodeficiency (PID) - NDPatients with PID diseases as Common Variable Immunodeficiency (CVID) or X-linked agammaglobulinemia ( XLA), age 1 to 70 years.MedDRA version: 6.1Level: PTClassification code 10057863EUCTR2006-006522-25-ITCSL Behring AG28
进行中（未招募）
不适用
A multicenter study on the efficacy and safety of Vivaglobin® in Previously Untreated Patients (PUPs) with Primary Immunodeficiency (PID)EUCTR2006-006522-25-BECSL Behring AG28
进行中（未招募）
不适用
A multicenter study on the efficacy and safety of Vivaglobin® in Previously Untreated Patients (PUPs) with Primary Immunodeficiency (PID)Patients with PID diseases as Common Variable Immunodeficiency (CVID) or X-linked agammaglobulinemia ( XLA), age 1 to 70 yearsMedDRA version: 8.1Level: LLTClassification code 10010112Term: Common variable immunodeficiencyEUCTR2006-006522-25-DECSL Behring AG28
进行中（未招募）
1 期
A multicenter study on the efficacy and safety of Vivaglobin® in Previously Untreated Patients (PUPs) with Primary Immunodeficiency (PID)Patients with PID diseases as Common Variable Immunodeficiency (CVID) or X-linked agammaglobulinemia ( XLA), age 1 to 70 yearsMedDRA version: 8.1Level: LLTClassification code 10010112Term: Common variable immunodeficiencyEUCTR2006-006522-25-GRCSL Behring AG18