EUCTR2015-001128-52-Outside-EU/EEA进行中（未招募）不适用
A Randomized, Open-Label, Multicenter, Multinational, Dose-Ranging, Historical Control Study of the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of ENB-0040 (Human Recombinant Tissue-Nonspecific Alkaline Phosphatase Fusion Protein) in Children with Hypophosphatasia (HPP)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 13
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1) Patients > 5 and < 12 years of age with open growth plates at time of enrollment
- •2) Tanner stage of 2 or less indicating pre-pubescence
- •3) Documented history of HPP, as evidenced by:
- •-Presence of HPP-related rickets on skeletal radiographs of the wrist and knee
- •-Serum alkaline phosphatase (ALP) below age-adjusted normal range
- •-Plasma PLP at least twice the upper limit of normal
- •4) 25(OH) vitamin D level > 20 ng/mL
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 13
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1) Serum calcium or phosphorus below age-adjusted normal range
- •2) History of sensitivity to any study drug constituent
- •3) Medical condition, serious intercurrent illness, or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study compliance, including all prescribed evaluations and follow-up activities
- •4) Treatment with an investigational drug within 1 month before start of study drug
- •5) Current enrollment in any other study involving an investigational new drug, device, or treatment for HPP (e.g., bone marrow transplantation)
- •6) Current evidence of a treatable form of rickets
- •7) Prior treatment with bisphosphonates
- •8) Bone fracture or orthopedic surgery within the past 12 months that, in the opinion of the Investigator would interfere with the ability of study patient to comply with study protocol
- •9) Major congenital abnormality other than those associated with HPP
研究者
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