EUCTR2017-001831-38-Outside-EU/EEA进行中（未招募）1 期
A Randomized, Open-Label, Multicenter, Multinational, Dose-Ranging, Concurrent Control Study of the Safety, Efficacy, and Pharmacokinetics of ENB-0040 (Human Recombinant Tissue-NonspecificAlkaline Phosphatase Fusion Protein) in Adolescents and Adults with Hypophosphatasia (HPP)
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 19
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
- •Patients must meet all of the following criteria for enrollment in this study:
- •- Patients or their legal representative(s) must provide written informed consent prior to undergoing any study-related procedures
- •- Patients must be = 13 and = 65 years of age at the time of study enrollment
- •- Female patients of childbearing potential and sexually mature males must agree to use a medically acceptable form of birth control; for the purposes of this study, females are considered of non-childbearing potential if they are surgically sterile (i.e., have undergone a total hysterectomy, bilateral salpingo-oophorectomy or tubal ligation) or are post-menopausal, defined as having complete cessation of menstruation for at least 1 year after 45 years of age
- •- Patients must have a pre-established clinical diagnosis of HPP as indicated by:
- •?Serum alkaline phosphatase (ALP) below the age-adjusted normal range
- •?Plasma PLP at least twice the upper limit of normal (no vitamin B6 administered for at least 1 week prior to determination)
- •?Evidence of osteopenia or osteomalacia on skeletal radiographs
- •- Patients must have osteomalacia on bone biopsy, characterized by an MLT z-score of +2 or more (results from ENB-001-08 may be used)
- •- Patients must be willing to comply with study procedures and the visit schedule
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 6
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 13
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •Patients will be excluded from enrollment in this study if they meet any of the following exclusion criteria:
- •- Women who are pregnant or lactating
- •- History of sensitivity to tetracycline
- •- Serum calcium or phosphate levels below the normal range
- •- Serum 25(OH) vitamin D below 20 ng/mL
- •- Serum creatinine or parathyroid hormone (PTH) levels above the upper limit of normal
- •- 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
- •- Orthopedic surgery within 12 months prior to study entry that may interfere with the ability to perform functional assessments for the study
- •- Prior treatment with bisphosphonates within 2 years of study entry for any length of time or for more than 2 years at any time point; for patients with prior bisphosphonate use that is allowed, the bone resorption markers serum C-telopeptide and urine N-telopeptide or urine deoxypyridinoline must also be within the normal range or elevated to be eligible for study participation
- •- Treatment with PTH within 6 months prior to the start of asfotase alfa administration
- •- Participation in an interventional or investigational drug study within 30 days prior to study participation
研究者
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